Suturing devices and methods

ABSTRACT

A surgical device for suturing body lumen is described, as well as methods for suturing tissue employing the surgical device. The device can include a body having a shaft and a foot for insertion into an opening in a body lumen. The device can include tissue ports between configured to receive tissue surrounding the opening in the body lumen. The foot can include a suture secured to needle capture devices. The device can include needles that can be advanced through tissue and into the needle capture devices. The needle capture devices can then be withdrawn, thereby harvesting the suture, which can then be used to close the opening in the body lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of an earlier filed U.S.patent application Ser. No. 12/873,728, filed Sep. 1, 2010, now U.S.Pat. No. 8,663,252, entitled “Suturing Devices And Methods,” the entirecontent of which is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems, andmethods. In particular, the present disclosure relates to devices andmethods for suturing of openings in body lumens. More specifically, thepresent invention relates to devices and methods for closing arterialand venous puncture sites.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as, for example,angioplasty, catheterization, and the placement of stents, are commonlyperformed by inserting a hollow needle through the skin and tissue of apatient into the patient's vascular system. A guide wire is then oftenadvanced through the needle and into the patient's blood vessel. Theneedle is then removed, enabling an introducer sheath to be advancedover the guidewire into the vessel, e.g., in conjunction with, orsubsequent to, a dilator. A catheter or other device may then beadvanced through a lumen of the introducer sheath and over the guidewireinto a position for performing a medical procedure. Thus, the introducersheath may facilitate introducing various devices into the vessel, whileminimizing trauma to the vessel wall and/or minimizing blood loss duringa procedure.

In practice, the introducer sheath is often inserted into the patient'svasculature using the modified Seldinger technique. In the Seldingertechnique, a needle is first inserted into the vessel and a guide wirethen follows through the needle. Next, the needle is removed and asheath/dilator combination is advanced over the guide wire. The dilatorexpands the puncture in the vessel to a size suitable to receive thedistal end of an introducer sheath. After the distal end of the sheathis disposed within the vessel, the dilator and guide wire are removed,thereby allowing access to the vessel lumen or other body lumen via theinserted introducer sheath.

Upon completing the diagnostic and/or treatment procedure, the devicesand introducer sheath are removed, leaving a puncture site in the vesselwall. One will appreciate that it is desirable to close the puncturesite in vessel wall. Closing the wound can be difficult due tosubstantial bleeding that can occur through an open wound in a bloodvessel. One method of closing the puncture site includes applyingexternal pressure to the puncture site until clotting and wound sealingoccur; however, the patient must remain bedridden for a substantialperiod after clotting to ensure closure of the wound. This procedure canbe time consuming and expensive, requiring as much as an hour of aphysician's or nurse's time. It also can be uncomfortable for thepatient and may require that the patient remain immobilized in theoperating room, catheter lab, or holding area. In addition, a risk ofhematoma exists from bleeding before hemostasis occurs.

Another method of puncture site closure is the use of bioabsorbablefasteners or sealing plugs. Bioabsorbable fasteners or sealing plugs canovercome many of the disadvantages associated with manual compression.Typically, these approaches rely on the placement of a thrombogenic andbioabsorbable material, such as collagen, at the superficial arterialwall over the puncture site. While potentially effective, this approachcan suffer from a number of disadvantages. For example, it can bedifficult to properly locate the interface of the overlying tissue andthe adventitial surface of the blood vessel. Placing the plug too farfrom that interface can result in failure to provide hemostasis, andsubsequent hematoma and/or pseudo-aneurysm formation. Conversely, if theplug intrudes into the artificial lumen, intravascular clots and/orcollagen pieces with thrombus attached can form and embolize downstream,causing vascular occlusion. Also, thrombus formation on the surface of aplug protruding into the lumen can cause a stenosis, which can obstructnormal blood flow. Other possible complications include infection, aswell as adverse reaction to the collagen or other implant.

Yet another approach for vascular closure includes the use ofsuture-applying devices. Conventional suture-applying devices areintroduced through the tissue tract and advanced until a distal end ofthe device extends through the puncture site. One or more needles in thedevice are then deployed and used to draw suture through the bloodvessel wall. Next, the suture is secured to provide closure of thepuncture site. While suture-applying devices can overcome many of thedifficulties associated with other puncture site closure devices andmethods, locating the tissue surrounding a puncture site can bedifficult using some suture-applying devices and methods. Somecomplications that may arise by misplaced or insufficiently anchoredsutures include oozing, excessive bleeding, and potential knotloosening.

BRIEF SUMMARY

Briefly summarized, implementations of the present invention providedevices and methods for closing openings in a body lumen efficiently andquickly. For example, one or more implementations of the presentinvention provide suturing devices with tissue ports configured to allowfor location of body lumen wall tissue surrounding a puncture site withincreased accuracy and ease. This method can provide for suturedeployment over the guide wire permitting rapid re-access to the vesselby the clinician. Furthermore, one or more implementations of thepresent invention can reduce miss-deployment of needles, and can allowfor closure of larger body lumen openings.

For example, in one implementation, a suturing device configured toclose an opening in a body lumen can include a shaft having a distal endand a proximal end. The distal end of the shaft can be defined by thedistal most surface of the shaft. The shaft can include a first needleexit opening extending through the distal end thereof. The shaft canfurther include a second needle exit opening extending through thedistal end thereof. The suturing device can further include a footmember secured to the distal end of the shaft. Additionally, thesuturing device can include first and second needle capture devicesremovably secured to the foot member. The suturing device can alsoinclude at least one length of suture removably secured to the footmember. The at least one length of suture can have a first end securedto the first needle capture device and a second end secured to thesecond needle capture device.

In another implementation, a suturing device configured to close anopening in a body lumen can include a shaft having a distal end and aproximal end. The suturing device can also include a foot having aproximal tissue location surface and a distal tip. Additionally, thesuturing device can include a spinal member connecting the foot memberto the shaft. Also, the suturing device can include an actuatorconfigured to move the foot from a first configuration, in which thetissue location surface is adjacent the distal end of the shaft, to adeployed configuration, in which the tissue location surface is distallyseparated from the distal end of the shaft by a length of the spinalmember.

In yet another implementation, a suturing device configured to close anopening in a body lumen can include an elongate member including aproximal portion and a distal portion. The suturing device can alsoinclude first and second needle lumens extending through the proximalportion of the elongate member to first and second needle exit openings.Furthermore, the suturing device can include first and second needlecapture devices secured to the distal portion of the elongate member.The first and second needle capture devices can be aligned with thefirst and second needle exit openings. Additionally, the first andsecond needle capture devices can be separated from the first and secondneedle exit openings by one or more tissue ports extending into theelongate member between the proximal portion and the distal portion. Thesuturing device can also include at least one length of suture withinthe distal portion of the shaft. The at least one length of suture canhave a first end secured to the first needle capture device and a secondend secured to the second needle capture device.

In addition to the foregoing, an implementation of a method of closingan opening in a body lumen wall can involve advancing a suturing deviceover a guidewire into the body lumen. The suturing device can include ashaft, a foot secured to a distal end of the shaft, and at least onetissue port located between the distal end of the shaft and the foot.The method can also involve advancing a pair of needles simultaneouslythrough the shaft, out of needle exit openings in the distal end of theshaft, through wall tissue of the body lumen located in at least onetissue port, and into a pair of needle capture devices secured to thefoot. Additionally, the method can involve withdrawing the pair ofneedles and the pair of needle capture devices from the suturing device,thereby at least partially withdrawing a suture connected to the pair ofneedle capture devices from the foot. Further, the method can involveemploying the suture to close the opening in the body lumen wall.

Another implementation of a method of closing an opening in a body lumenwall can involve advancing a suturing device into the opening of thebody lumen wall. The suturing device can include a shaft and a footsecured to a distal end of the shaft. The method can further involvearticulating the foot from a first configuration in which the foot isadjacent a distal end of the shaft to a deployed configuration in whichthe foot is distally separated from the distal end of the shaft. Themethod can also involve advancing one or more needles through the shaft,through wall tissue of the body lumen located in between the shaft andthe foot, and into one or more needle capture devices secured to thefoot. The method can additionally involve employing the suture to closethe opening in the body lumen wall.

One implementation includes a suturing device configured to close anopening in a body lumen. The suturing device may have a shaft having adistal end and a proximal end. Additionally, the suturing device caninclude a first needle lumen disposed within the shaft, the first needlelumen terminating at a first needle exit opening at the distal end ofthe shaft and a second needle lumen disposed within the shaft, thesecond needle lumen terminating at a second needle exit opening at thedistal end of the shaft. The suturing device also can include a guidemember slidably located within the shaft and extending past the distalend of the shaft and a foot member coupled to the guide member, aproximal end of the foot member being positioned proximally to thedistal end of the shaft. Furthermore, the suturing device can include afirst needle capture device removably secured to the foot member and asecond needle capture device removably secured to the foot member. Thesuturing device also can incorporate at least one length of sutureremovably secured to the foot member, the at least one length of suturehaving a first end secured to the first needle capture device and asecond end secured to the second needle capture device.

One or more other implementations include a suturing device configuredto close an opening in a body lumen. The suturing device can have ashaft having a distal end and a proximal end, a first needle lumendisposed within the shaft, the first needle lumen terminating at a firstneedle entrance opening at the distal end of the shaft, and a secondneedle lumen disposed within the shaft, the second needle lumenterminating at a second needle entrance opening at the distal end of theshaft. The suturing device also can include a guide member slidablypositioned within the shaft and extending past the distal end of theshaft, the guide member having a first needle and a second needle, thefirst and second needles having piercing ends oriented in a proximaldirection. Moreover, the suturing device can include a cable connectedto the first and second needles, the cable being configured to move theneedles in the proximal direction and a length of suture having a firstand second ends thereof secured to the first and second needles.Additionally or alternatively, the suturing device can include a footcoupled to the guide member, the foot having a first needle connectorlumen and a second needle connector lumen, the first and second needleconnector lumens being configured to guide the first and second needlesout of the guide member and into the first and second entrance openingsin the shaft.

Implementations of the present invention also include a method ofclosing an opening in a body lumen. The method can have various acts,which can include but are not limited to inserting a guide member of asuturing device through the opening and into the body lumen andinserting a foot of the suturing device into the opening and capturingtissue surrounding the opening in one or more tissue ports of the foot.Additionally, the method can include an act of adjusting a shaft of thesuturing device in a manner that needle exit openings located in theshaft correspond with needle capture devices located in the foot.Furthermore, the method can include an act of passing a plurality ofneedles through the shaft, out of the needle exit openings, through thetissue surrounding the opening, and into corresponding needle capturedevices. The method also can include an act of retrieving the pluralityof needles together with the corresponding needle capture devices,thereby passing a length of suture attached to the needle capturedevices through the tissue surrounding the opening.

Additional features and advantages of exemplary implementations of theinvention will be set forth in the description which follows, and inpart will be obvious from the description, or may be learned by thepractice of such exemplary implementations. The features and advantagesof such implementations may be realized and obtained by means of theinstruments and combinations particularly pointed out in the appendedclaims. These and other features will become more fully apparent fromthe following description and appended claims, or may be learned by thepractice of such exemplary implementations as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It should be noted that thefigures are not drawn to scale, and that elements of similar structureor function are generally represented by like reference numerals forillustrative purposes throughout the figures. Understanding that thesedrawings depict only typical embodiments of the invention and are nottherefore to be considered to be limiting of its scope, the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a perspective view of a suturing device with apassive foot in accordance with an implementation of the presentinvention;

FIG. 2 illustrates an exploded, cross-sectional view of the suturingdevice of FIG. 1;

FIG. 3 illustrates a cross-sectional view of the suturing device of FIG.1 with the needles thereof deployed;

FIG. 4 illustrates a perspective view of a needle capture device andassociated needle for use in the suturing device of FIG. 1;

FIG. 5 illustrates a partial, cross-sectional view of the suturingdevice of FIG. 1 taken along the line 5-5 of FIG. 1;

FIG. 6 illustrates a cross-sectional view of the suturing device of FIG.1 taken along the line 6-6 of FIG. 1;

FIGS. 7A-7G illustrate cross-sectional views of a body lumen, showing amethod for closing an opening in the wall of the body lumen using thesuturing device of FIG. 1;

FIG. 8A illustrates a perspective view of another suturing device havinga non-articulating foot in accordance with an implementation of thepresent invention;

FIG. 8B illustrates a cross-sectional view of the suturing device ofFIG. 8A taken along the line 8B-8B of FIG. 8A;

FIG. 8C illustrates a cross-sectional view of the suturing device ofFIG. 9A taken along the line 8C-8C of FIG. 8B;

FIG. 9A illustrates a perspective view of a suturing device having anon-articulating foot in accordance with another implementation of thepresent invention;

FIG. 9B illustrates a cross-sectional view of the suturing device ofFIG. 9A taken along the line 9B-9B of FIG. 9A;

FIG. 9C illustrates a cross-sectional view of another implementation ofthe suturing device of FIG. 9A;

FIG. 10A illustrates a perspective view of a suturing device with anarticulating foot in parked configuration in accordance with animplementation of the present invention;

FIG. 10B illustrates an enlarged view of the shaft and articulating footof the suturing device of FIG. 10A;

FIG. 11A illustrates a perspective view of the suturing device of FIG.10A with the articulating foot in a deployed configuration;

FIG. 11B illustrates an enlarged view of the shaft and articulating footof the suturing device of FIG. 11A;

FIG. 11C illustrates a further enlarged view of the articulating foot ofthe suturing device of FIG. 11A;

FIG. 12A illustrates an end view of a foot actuator mechanism with alocking mechanism for use in the suturing device of FIG. 10A inaccordance with an implementation of the present invention;

FIG. 12B illustrates the foot actuator mechanism and locking mechanismof FIG. 12A with the locking mechanism engaged;

FIGS. 13A-13I illustrate cross-sectional views of a body lumen, showinga method for closing an opening in the wall of the body lumen using thesuturing device of FIG. 10A;

FIG. 14 illustrates a perspective view of a suturing device with areplaceable foot in accordance with one implementation of the presentinvention;

FIG. 15A illustrates a cross-sectional view of a suturing device with areplaceable foot in accordance with one implementation of the presentinvention;

FIG. 15B illustrates a cross-sectional view of a suturing device with areplaceable foot in accordance with another implementation of thepresent invention;

FIG. 16A illustrates a top view of a foot of a suturing device inaccordance with one implementation of the present invention;

FIG. 16B illustrates a top view of the foot illustrated in FIG. 16Bshown in a deformed state;

FIG. 17A illustrates a cross-sectional view of a suturing device with areplaceable foot in a pre-deployed configuration in accordance with yetanother implementation of the present invention;

FIG. 17B illustrates a cross-sectional view of a suturing device of FIG.17A in a deployed configuration;

FIG. 18 illustrates a partial cross-sectional view of a suturing devicein accordance with still another implementation of the present inventionshown in a deployed configuration; and

FIGS. 19A-19F illustrate cross-sectional views of a body lumen, showinga method for closing an opening in the wall of the body lumen using thesuturing device of FIG. 14.

DETAILED DESCRIPTION

As previously mentioned, implementations of the present inventioninclude devices and methods for closing openings in a body lumenefficiently and quickly. For example, one or more implementations of thepresent invention provide suturing devices with tissue ports configuredto allow for location of body lumen wall tissue surrounding a puncturesite with increased accuracy and ease. This method can provide forsuture deployment over the guide wire permitting rapid re-access to thevessel by the clinician. Furthermore, one or more implementations of thepresent invention can reduce miss-deployment of needles, and can allowfor closure of larger body lumen openings.

In particular, one implementation of the present invention can include asuturing device having a body including a shaft and a foot for insertioninto an opening in a body lumen. The body can include tissue portsbetween the shaft and the foot configured to receive tissue of the bodylumen surrounding the opening. The foot can include a suture secured toneedle capture devices. Needles can be advanced within the shaft,through tissue within the tissue ports, and into the needle capturedevices. The needle capture devices can then be withdrawn, therebyharvesting the suture, which can then be used to close the opening inthe body lumen.

In some implementations of the present invention, the tissue ports inthe body of the suturing device can be passive. In other words, thetissue ports can be formed between the shaft and the foot and remainopen at all times. In alternative implementations, the tissue ports canbe non-passive. In such implementations, the foot can articulate betweena pre-deployed configuration and deployed configuration. In thepre-deployed configuration the tissue ports can be at least partiallyclosed. For example, in one implementation the foot can abut against theshaft when in the pre-deployed configuration. In the deployedconfiguration the tissue ports can be open. For example, in oneimplementation the foot can be distally displaced from the foot when inthe deployed configuration, thereby opening tissue ports between thefoot and the shaft. In implementations including an articulating foot,the foot can be used to draw or push tissue surrounding an opening in abody lumen into the tissue ports.

Additionally, one or more implementations of the present inventioninclude devices and procedures that allow a medical practitioner toinsert a first suturing device over a guidewire into a tissue opening,deploy at least one suture, and remove the suturing device from thetissue opening before removing the guidewire. One will appreciate thatthis can allow the medical practitioner to run an additional suturingdevice over the same guidewire if the medical practitioner is not ableto close the tissue opening using the first suturing device. Forexample, if needles used to harvest the suture of the first suturingdevice miss-deploy or otherwise fail to harvest the suture, the medicalpractitioner can remove the first suturing device and deploy anotherwithout having to place a second guidewire.

As an initial matter, as used herein, the term “proximal” refers to adirection toward a user (i.e., a medical practitioner or surgeon) of asuturing device and away from the patient, or a location closer to theuser of the suturing device. As used herein, the term “distal” refers toa direction towards the patient and away from the user of the suturingdevice, or a location closer to the patient.

Turning now to the Figures, FIG. 1 shows an implementation of a suturingdevice 100 for closing an incision, a puncture, a passage, or openingthrough tissue or a body lumen. In particular, the implementation shownby Figure in is a suturing device 100 that includes passive tissueports. In some examples, the suturing device 100 can close communicationwith a blood vessel or other body lumen. As shown in FIG. 1, thesuturing device 100 can include a body or elongate member 102. The body102 can have an annular configuration positioned about a central axis.For example, the body 102 illustrated in FIG. 1 includes a circularcross-section. In additional implementations, the body 102 may includeother noncircular shapes as well, such as elliptical or othersymmetrical or non-symmetrical shapes.

In any event, the body 102 can include a proximal portion or shaft 104and a distal portion or foot 106. FIG. 1 further illustrates that thesuturing device 100 can include a flexible, guidebody 109 extendingdistally from the distal end of the foot 106. As explained in greaterdetail below, the guidebody 109 can be advanced along a guidewire into abody lumen. Thus, at least the distal portion of the guidebody 109 canbe formed from a flexible or elastomeric material that is biocompatible,particularly with blood. For example, in some implementations theguidebody 109 can be composed of a biocompatible polymeric material,such as, for example, silicone rubber, polyolefin, polyurethane,polytetrafluoroethylene, nylon, pebax, KYNAR, or similar materials. Inadditional implementations, the guidebody can be coated or impregnatedwith a lubricant, bioactive agent, such as an anticoagulant material,Polyvinylpyrrolidone (PVP), or the like. For example, the bioactiveagent may have any therapeutic effect. Examples of additional suitabletherapeutic properties may include anti-proliferative,anti-inflammatory, antiplatelet, anti-fibrin, antithrombotic,antimitotic, antibiotic, antiallergic, antioxidant properties, and/orother therapeutic properties.

For example, a bioactive agent may be used to reduce scar tissueresponse when after the guidebody is withdrawn from the tissue of a bodylumen. Reducing scar tissue response, structural tissue response,restenosis, and/or thrombosis may facilitate access to the tissue afterthe opening has been sutured. For example, if a device did not use abeneficial agent to reduce scar tissue response, structural tissueresponse, restenosis, and/or thrombosis after deployment, these and/orother tissue responses may hinder future access to the tissue.

The foot 106 can include a flared portion that extends radially outwardof the guidebody 109 and/or shaft 104. The foot 106 may be machined orcast from a composite material, such as, for example, carbon fiber. Insome implementations, the foot 106 can be molded as two separate halveswhich can be subsequently affixed together. In yet furtherimplementations, the foot 106 may comprise a biocompatible material,such as, for example, stainless steel, nylon, or similar materials.

The shaft 104 can include a proximal end 108 and a distal end 110 (i.e.,the terminal end or surface of the shaft 104). The shaft 104 cancomprise a biocompatible material, such as stainless steel, carbonfiber, nylon, another suitable polymer, or similar materials.Furthermore, in some implementations the shaft 104 may be flexible toaccommodate insertion into a body lumen. In alternative implementations,the shaft 104 may comprise a rigid construction so as to avoidsubstantial deflection during use.

A handle 112 can be secured to the proximal end 108 of the shaft 104.The handle 112 can be of sufficient dimensions to allow a medicalpractitioner to grasp the handle 112 and use it to manipulate thesuturing device 100 during use. Furthermore, the handle 112 can supporta needle actuation handle 114. The proportions of the needle actuationhandle 114 and needles 122/124 may be change with respect to each otherto improve needle stroke and column strength. The handle 112 and theneedle actuation handle 114 may include a bioabsorbable metal, alloy,polymer, plastic, composite, other materials, or combinations thereof.

The handle 112 can have any number of suitable configurations. In someembodiments, the handle 112 can have a syringe grip configuration. Forinstance, the handle 112 can include opposing loops, which canaccommodate user's fingers therein. Alternatively or additionally, thehandle 112 can incorporate locations for user's fingers (e.g., thehandle 112 can extend outward and bend away from the user). As such, theuser can have a secure grip of the handle 112 as well as of the shaft104.

The foot 106 can be secured to the distal end 110 of the shaft 104 by aspinal member 116. The spinal member 116 can separate the distal end 110of the shaft 104 from the foot 106, and thus, define one or more tissueports 118, 120. In some embodiments, the spinal member 116 comprisesstainless steel, nitinol, or a similar material. The spinal member 116can be composed of a biocompatible material that is substantiallyresistant to deformation, and therefore, can maintain alignment betweenthe needle lumens 126, 128 and the needle capture devices 136, 138. Itshould be appreciated that the needle lumens 126, 128 can have anynumber of suitable configurations. For instance, the needle lumens 126,168 can be substantially straight or linear. Alternatively, the needlelumens 126, 128 can be bent, angles, or may have any number ofnon-linear configurations. In any event, however, the needle lumens 126,128 can be shaped, positioned, and oriented in a manner that allows theneedles 122, 124 align with the needle capture devices 136, 138. Onewill appreciate that the spinal member's resistance to deformation canhelp ensure that needles 122, 124 are not miss-deployed. Furthermore,the spinal member can serve to maintain structural integrity between theshaft 104 and foot 106. Examples of suitable materials include stainlesssteel, polytetrafluoroethylene, nylon, polyamids, and similar materials.

Furthermore, FIG. 5 illustrates that the spinal member 116 can have awidth equal to approximately the diameter of the foot 106. Thus,referring again to FIG. 1, the spinal member 116 can define two tissueports 118, 120 separating the distal end 110 of the shaft 104 from thefoot 106. In alternative implementations, the spinal member 116 can havea width smaller than the diameter of the shaft 104, and thus, define asingle circumferential tissue port. Alternatively, the suturing device100 can include three or more tissue ports.

In any event, the body 102 can include one or more tissue ports 118, 120separating the distal end 110 of the shaft 104 from the foot 106. Asexplained in greater detail below, the tissue ports 118, 120 can beconfigured to receive tissue surrounding an opening, such as a puncturewound, in a body lumen wall. The tissue ports 118, 120 can thus helplocate the tissue surrounding an opening, and allow for the suturing ofthe tissue to close the opening.

Referring now to FIGS. 2 and 3, an exploded cross-sectional view and anassembled cross-sectional view, respectively, of the suturing device 100are illustrated. As shown, the needle actuation handle 114 can includeone or more needles secured thereto. In particular, the implementationshown in FIGS. 2 and 3 includes a first needle 122 and a second needle124. In additional implementations, the suturing device 100 can includea single needle or three or more needles.

One or more of the needles for use with the suturing devices of thepresent invention can be provided as substantially described in U.S.Pat. No. 6,136,010 issued to Modesitt et al. and/or U.S. Pat. No.5,792,152 issued to Klein et al., which are incorporated herein byreference in their entirety. As such in some implementations, theneedles for use with the present invention can be flexible.Alternatively, needles for use with the present invention can be rigid.In particular, the needles can include sufficient column strength so asto avoid any meaningful deflection as they are advanced through tissue.By having a rigid construction, the needles can pass from the shaft 104,through tissue within the tissue ports 118, 120, and into the foot 106without deflection. One will appreciate that this can help decrease oreliminate miss-deployment of needles sometimes associated with flexibleneedles. For example, a rigid construction can help ensure that theneedles 122, 124 pass into the foot, instead of deflecting and missingthe foot 106, or more specifically engagement features within the foot106.

In any event, the needle actuation handle 114 can be engageable with orbe secured to one or more needles. For example, FIG. 2 illustrates thatthe needle actuation handle 114 can be secured to the first needle 122and the second needle 124. The needle actuation handle 114 can be sizedto be positioned within a receptacle 125 extending into the proximal end108 of the handle 112 and/or shaft 104. The needle actuation handle 114can allow a medical practitioner to advance the needles 122, 124 intothe shaft 104 and then the foot 106. Specifically, the needle actuationhandle 114 can be configured such that a medical practitioner canadvance the needles 122, 124 in a proximal direction toward the patient,and then subsequently in a distal direction away from the patient. Inalternative implementations, the suturing device 100 may not include aneedle actuation handle 114. In such implementations, the proximal endsof the needles 122, 124 can be configured to held and manipulated by themedical practitioner to advance and retract the needles 122, 124.

In some embodiments, the suturing device 100 can incorporate a spring,which can resist and/or prevent unintentional movement of the needleactuation handle 114. In other words, the spring may have to becompressed to advance the needle actuation handle 114. Accordingly, thespring may prevent unintentional engagement of the needles 122, 124 withthe needle capture devices 136, 138.

FIGS. 2 and 3 illustrate that the shaft 104 of the body 102 can includea plurality of axial lumens therein. For example, FIGS. 2 and 3illustrate that the shaft 104 can include a pair of needle lumens 126,128. The needle lumens 126, 128 can extend from the proximal end 108 tothe distal end 110 of the shaft 104. In particular, the distal end 110end of the shaft 104 can include a first needle exit opening 130 and asecond needle exit opening 132, at the respective ends of the needlelumens 126, 128. The needle lumen 126, 128 can guide the needles 122,124 from the proximal end 108 of the shaft 104, through the shaft 104,and out of the needle exit openings 130, 132.

In addition to the needle lumens 122, 124, the shaft 104 can includeadditional lumens. For example, the shaft 104 can include a footposition verification lumen, such as that described herein below inreference to the suturing device 300 shown in FIGS. 10A-13I.Additionally, as shown in FIGS. 2 and 3, the shaft 104 can include aguidewire lumen 134. The guidewire lumen 134 can extend along the lengthof the shaft 104, through the foot 106, and through the guidebody 109.The guidewire lumen 134 can extend substantially along the central axisof the suturing device 100 as shown in FIGS. 2 and 3, or alternativelybe offset from the central axis of the suturing device 100. Furthermore,in some implementations, the guidewire lumen 134 can serve as the spinalmember 116.

The guidewire lumen 134 can receive or follow a guidewire left in placeafter a diagnostic or medical procedure. In particular, as explained ingreater detail below, a medical practitioner can insert the suturingdevice 100 into a body lumen or other site to be repaired by sliding theguidewire lumen 134 over the pre-placed guidewire. For example, amedical practitioner can place an opening 135 in the distal end of theguidebody 109 over a guidewire (not shown). The guidewire can thenextend through the guidewire lumen 134 and out of the needle actuationhandle 114. Thus, the guidewire can extend out of the proximal end ofthe suturing device 100 without interfering with the needles 122, 124,needle lumens 126, 128, or suture. The guidewire can be removed afterplacement of the suturing device 100 in a body lumen, after deploymentof the needles 126, 128, or after removal of the suturing device 100from the patient, as considered prudent by the medical practitioner.

In addition to the guidewire lumen 134, the foot 106 can include one ormore needle capture devices. For example, FIGS. 2 and 3 illustrate thatthe foot 106 can include a first needle capture device 136 and a secondneedle capture device 138. In alternative implementations, the foot 106can include one needle capture device or three or more needle capturedevices. One will appreciate that the number of needle capture devicesin the foot 106 can correspond to the number of needles 122, 124 andneedle lumens 126, 128 in the shaft 104. Each needle capture device 136,138 can correspond to and be aligned with a needle lumen 126, 128, and aneedle exit opening 130, 132. One will appreciate that by being aligned,the needles 122, 124 can pass out of the needle exit openings 130, 132,through the tissue ports 118, 120 and into the needle capture devices136, 138.

The needle capture devices 136, 138 can be secured to a suture 140removably stored within a suture lumen 142 within the foot 106 and/orguidebody 109. For example, FIGS. 2 and 3 illustrates that the suturingdevice 100 includes a length of suture 140 having its respective endssecured to the first and second needle capture devices 136, 138. Inparticular, as illustrated by FIG. 6, the suture lumen 142 can extend atleast partially around the guidewire lumen 134 and allow the suture 140to wrap from the first needle capture device 136 to the section needlecapture device 138. In alternative implementations, each needle capturedevice 136, 138 can have two or more sutures, ends or otherwise, securedthereto. As explained in greater detail below, multiple sutures may bedesirable when closing larger openings or punctures within a body lumen.

The various implementations of the present invention may include any ofa variety of suture types, such as, for example, monofilament or braidedsutures. The sutures may be absorbable or non-absorbable, and may bemade of polyester, polypropylene, polyglycolic acid, nylon, silk, or anyof a variety of different materials.

Referring again to FIGS. 2 and 3, the suture 140 and the suture lumen142 can extend from the foot 106 into the guidebody 109. In alternativeimplementations, the entire suture, or a substantially portion thereof,may be housed within the foot 106. For example, in some implementations,the suture 140 can be coiled and stored within the flared portion of thefoot 106. In yet further implementations, the suture 140 can be storedor attached to the outer surfaces of the foot 106 or guidebody 109.

As shown by FIGS. 2 and 3, the needle capture devices 136, 138 can beconfigured to receive and secure the needles 122, 124 to the suture 140.In particular, once the needles 122, 124 are advanced into the needlecapture devices 136, 138, the needle capture devices 136, 138 can lockthe needles 122, 124 therein. Thereafter, when the needles 122, 124 areretracted from the foot 106 and the shaft 104, the needles 122, 124 canpull the suture 140 at least partially from the foot 106, through theneedle lumens 126, 128, and out of the proximal end 108 of the shaft 104or suturing device 100. In particular, by retracting the needles 122,124, the suture 140 can be removed from the foot 106. Specifically, thesuture 140 can pass out of the opening of the suture lumen 142 in thetissue location surface 144 (FIG. 5). Once the suture 140 has beenharvested from the suturing device 100, the medical practitioner canremove the suturing device 100, retrieve the suture 140, and use it toclose or otherwise seal an opening in a body lumen.

The needle capture devices 136, 138 can be substantially flush with atissue location surface 144 (i.e., the surface of the foot opposite thedistal end 110 of the shaft 104) as shown in FIGS. 2 and 3.Alternatively, the needle capture devices 136, 138 can reside furtherwithin the foot 106, as explained in greater detail below with referenceto FIG. 9C. In such implementations, the foot 106 can include needlereceiving lumens or funnels that extend from the tissue location surface144 to the needle capture devices 136, 138, and that can guide theneedles 122, 124 into the needle capture devices 136, 138.

As shown by FIGS. 2 and 3, the needles 122, 124 can be advanced in adistal direction from the proximal end 108 of the shaft 104 within theneedle lumens 126, 128 by pressing the needle actuation handle 114 intothe receptacle 125 of the handle 112 and/or shaft 104. The needles 122,124 can advance out of the needle exit openings 130, 132, through tissuelocated within the tissue ports 118, 120, and into the needle capturedevices 136, 138 within the foot 106. By being inserted into the needlecapture devices 136, 138, the needle needles 122, 124 can be locked orsecured to the suture 140. The needles 122, 124 and suture 140 can thenbe withdrawn proximately through the needle tracts formed in the tissuewithin the tissue ports 118, 120, and proximally out of the shaft 104through the needle lumens 126, 128. In particular, by retracting theneedles 122, 124, the suture 140 can be removed from the foot 106.Specifically, the suture 140 can pass out of the opening of the suturelumen 142 in the tissue location surface 144 (FIG. 5). Once the needles122, 124 and suture 140 have been withdrawn from the foot 106, thesuturing device 100 can be withdrawn from the patient. The suture 140can then be drawn tight, closing the opening in the body lumen. Asurgical knot or other suture securing device (e.g., a cleat) cancomplete the closure of the opening in the body lumen.

As previously mentioned, the needles 122, 124 can be configured toengage the needle capture devices 136, 138. One will appreciate that theneedles 122, 124 and the needle capture devices 136, 138 can includevarious configurations so long as the needle capture devices 136, 138can secure the needles 122, 124 to the suture 140, and allow the suture140 to be harvested. For example, the needle capture devices 136, 138 ofthe present invention can include a net or other structure configured toreceive and lock a needle to the suture 140.

In some implementations, as illustrated by FIG. 4, a needle 122 a caninclude a barbed end 146 defining a recessed engagement surface 148. Theneedle capture device can comprise a needle attachment fitting or cuff136. Specifically, the needle attachment cuff 136 can have a roughlycylindrical shape and include an axial channel 150 configured to receivethe barbed end 146 of needle 122 a therein. In additionalimplementations, the needle attachment cuff 136 can include shapes otherthan cylindrical ones, such as, for example, conical. The needleattachment cuff 136 can include one or more features configured to lockthe barbed end 146 of the needle 122 a therein. For instance, as shownin FIG. 4, the needle attachment cuff 136 can include at least one tab152. The tab 152 may be mechanically formed to be smaller than thediameter of surface 148. The tab 152 can be resiliently biased intochannel 150. As the needle 122 a advances into the needle attachmentcuff 136, the barbed end 146 can displace the tab 152 clear of thechannel 150 so as to allow the barbed end 146 of the needle 122 a topass axially into the channel 105 of the needle attachment cuff 136.Once the barbed end 146 is disposed axially beyond the tab 152, the tab152 tab can flex back into the channel 150 over the recessed surface148, thereby locking the needle 122 a to the needle attachment cuff 136.One will appreciate that each needle attachment cuff can include morethan one tab 152, which can increase the reliability of the attachmentbetween the needle 122 a and the needle attachment cuff 136.

Additionally, FIG. 4 illustrates that the needle attachment cuff 136 caninclude a collar 154 to facilitate attachment of the needle attachmentcuff 136 to suture 140. For instance, the collar 154 can be crimpedabout the suture 140 to mechanically affix the suture 140 to the needleattachment cuff 136. In addition and/or instead of mechanical crimping,the suture 140 may be bonded to the needle attachment cuff 136 using anadhesive, heat, fasteners, knots, or the like. As shown by FIG. 5, thefoot 106 can house the needle attachment cuff 136. Or in other words,the needle attachment cuff 136 can extend distally into the tissuelocation surface 144 of the foot 106. In particular, in oneimplementation, the foot 106 can house a pair of needle attachment cuffs136 on opposing sides of the spinal member 116 and/or guidewire lumen134 (i.e., within the tissue ports 118, 120). FIG. 6A illustrates across-sectional view of the flexible guidebody 109. As shown by FIG. 6A,and as previously mentioned, the guidewire lumen 134 and suture lumen142 can extend into the flexible guidebody 109 in one or moreimplementations.

As mentioned previously, the needle capture devices 136, 138 can beremovably secured to the foot 106 so they can be withdrawn proximallyinto the shaft 104 as the needles 122, 124 are withdrawn. Additionally,one will appreciate that the outer body of the needle capture devices136, 138 can be configured with a taper or other feature to help allowthe needle capture devices 136, 138 to be readily pulled through pathsformed by the needles 122, 124 in tissue located within the tissue ports118, 120 when the practitioner retracts the needles 122, 124 and theneedle capture devices 136, 138 from the patient.

Reference is now made to FIGS. 7A-7G, which illustrate oneimplementation of a method of using the suturing device 100 to close anopening 210 in a body lumen 200. Specifically, the suturing device 100can be inserted in a distal direction into the body lumen 200. This canbe accomplished with or without the use of a guidewire. FIGS. 7A-7Gillustrate an example in which a guidewire 202 is used.

In particular, FIG. 7A illustrates that after accessing a body lumen, inthis case a blood vessel 200, (using the Seldinger or a ModifiedSeldinger technique, for example), a guidewire 202 may be left extendinginto skin 204 and down through tissue 206 along a tissue tract 208,which may have been formed by an introducer sheath previously placed inconnection with a intravascular medical or diagnostic procedure. Asshown by FIG. 7A, the guidewire 202 may enter the body lumen 200 throughan opening or puncture site 210 formed in the body lumen wall 212. Theguidewire 202 may extend along the body lumen 200. As illustrated byFIGS. 7A-7B, the flexible guidebody 109 can be advanced over theguidewire 202 in a monorail fashion, so that the guidewire 202 helpsdirect the suturing device 100 along the tissue tract 208 into the bodylumen 200 through the opening 210.

As shown by FIGS. 7B-7C, the suturing device 100 can be slowly advanceduntil resistance is encountered as the tissue ports 118, 120 cross thelumen wall 212 into the body lumen 200. The resistance can be providedby the radial flare of the foot 106 and/or by the distal end of theshaft 104. Alternatively, or additionally, the suturing device 100 canbe advanced until blood is observed in a position indicator, such asthat described below in relation to suturing device 300. In any event,once properly positioned, the suturing device 100 can be stabilizedpermitting the tissue 214 surrounding the opening 210 to rebound intothe tissue ports 118, 120, as depicted in FIG. 7C.

As shown in FIG. 7D, once the tissue 214 has entered into the tissueports 118, 120, the needles 122, 124 can be advanced in a distaldirection within the needle lumens 126, 128, out of the needle exitopenings 130, 132, distally across the tissue ports 118, 120 through thetissue 214, and into the needle capture devices 136, 138. The needles122, 124 and needle capture devices 136, 138 can then be withdrawn outof the foot 106, proximally across the tissue ports 118, 120 through thetissue 214, and out of the proximal end of the suturing device 100, asdepicted by the arrow in FIG. 7E. FIG. 7E further shows that bywithdrawing the needles 122, 124 and needle capture devices 136, 138,the distal end of the suture 140 can be withdrawn proximally out of theopening of the suture lumen 142 in the tissue location surface 144 andout of the foot 106.

As indicated by the arrow of FIG. 7F, the suturing device 100 can nextbe withdrawn from the body lumen 200 and out of the tissue tract 208.The suture can then be severed, leaving sufficient length for the userto grasp the suture (by hand or with a tool) as well as to closure theopening 210, as further described below. As shown by FIG. 7F, theguidewire 202 can remain in place during the entire sequence to thispoint if desired. Thus, if the suture 140 fails to capture the tissue214, or otherwise allow for the suture 140 to close the opening 210,another suturing device 100 can be inserted along the guidewire 202, andthe above procedure repeated. One will appreciate that the ability toreuse the guidewire 202 if a problem is encountered can reduce the time,effort, and cost associated with resolving the problem and obtaining adry closure of the body lumen 200.

Finally, FIG. 7G illustrates that the guidewire 202 can be pulled fromthe patient. At this point, or prior thereto, the suture 140 can beemployed to close the opening 210 in the body lumen 200. In particular,a surgical knot 158 can be tied securing the wound closure. A knotpusher, for example, the knot pushers described in U.S. Pat. No.5,304,184 issued to) Hathaway et al., U.S. Pat. No. 5,746,755 issued toWood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be usedto advance the loosely tied knot to the exterior surface of the vascularvessel. In some implementations, the medical practitioner can then tie asuitable surgical knot 158 using the respective lengths of suture 140 toclose the opening 210 (FIG. 7A). In other embodiments, the suture 140can be secured using a variety of knot replacement technologies such asthose disclosed in U.S. Pat. No. 7,108,710 issued to Anderson. Each ofthe above-identified patents are incorporated herein by reference intheir entirety.

In some cases, particularly for closure of large openings or punctures,it may be advantageous to provide multiple sutures 140 across theopening 210, either in parallel, in an “X” pattern, or in anotherconfiguration. For example, FIGS. 8 and 9 illustrate various views of asuturing device 100 a similar to suturing device 100, except thatsuturing device 100 a includes the use of more than two needles andassociated needle lumens, needle capture devices, sutures, and the like.In particular, the suturing device 100 a can include four needle lumens124, 126, 124 a, 126 a, and four associated needles, four needle capturedevices, and two sutures. Additional implementations of the presentinvention having multiple suture systems may have six, eight, or ten ormore needles, or may even have odd numbers of needles and needle capturedevices, particularly where one or more needle capture devices have aplurality of suture ends extending there from. This can allow a widevariety of stitching patterns to be provided by such multiple loopimplementations.

More particularly, FIG. 8 illustrates that the suturing device 100 a caninclude a shaft 104 and a distal portion or foot 106. FIG. 8 furtherillustrates that the suturing device 100 a can include a flexible,guidebody 109 extending distally from the end of the foot 106. The foot106 can include a flared portion that extends radially outward of theguidebody 109 and/or shaft 104. The shaft 104 can include a proximal end108 and a distal end 110. A handle 112 can be secured to the proximalend 108 of the shaft 104. The handle 112 can be of sufficient dimensionsto allow a medical practitioner to grasp the handle 112 and use it tomanipulate the suturing device 100 a during use. Furthermore, the handle112 can support a needle actuation handle 114.

Furthermore, as illustrated by FIGS. 8 and 9A, the spinal member 116 acan have a circular cross-section and a diameter several times smallerthan the diameter of the shaft 104 and/or foot 106. Thus, the suturingdevice 100 a can include a single, circumferential tissue port 118 a. Inyet further implementations, suturing devices of the present inventioncan include a single tissue port that extends only partially around thecircumference of the shaft 104 and foot 106. In additionalimplementations, suturing devices of the present invention can includethree, four, five, or more tissue ports.

FIGS. 8A and 8B further illustrate that the suturing device 100 a caninclude one or more suture exit slots 160. The suture exit slots 160 canextend from inside the foot 106 and/or guidebody 109 from the sutures140, radially outward and in a proximal direction. The suture exit slots160 can replace the opening of the suture lumen 142 in the tissuelocation surface 144 used in the suturing device 100 and function toallow the sutures 140 to be pulled radially out from the foot 106 and/orguidebody 109 as the needles and needle capture devices are withdrawnproximally from the suturing device 100 a. In other words, the sutures140 can be pulled out of, and separated from foot 106 and/or guidebody109 as the needles and needle capture devices are distally withdrawn(i.e., before the shaft 104, foot 106, and guidebody the suturing device100 a are withdrawn). One will appreciate that by having the suture exitslots 160, the space needed within the foot 106 and/or guidebody 109 tohouse the sutures 140 may be reduced.

FIGS. 8B, 8C further illustrate that the suturing device 100 a caninclude retaining slots 161. The retaining slots 161 can be configuredto allow the foot 106 to receive and retain therein needle capturedevices 136 a, 138 a. For example, the ports within the foot 106 withinwhich the needle capture devices 136 a, 138 a can have a diametersmaller than the outer diameter of the needle capture devices 136 a, 138a. The retaining slots 161 can allow the ports, which hold the needlecapture devices 136 a, 138 a within the foot 106, to expand to receivethe needle capture devices 136 a, 138 a. Once within the ports of thefoot 106, the retaining slots 161 can allow the ports to bias toward andretain the needle capture devices 136 a, 138 a therein.

As alluded to earlier, the suturing devices of the present invention caninclude needle receiving lumens or funnels for guiding the needles intothe needle capture devices 136 a, 138 a. For example, FIGS. 9A and 8Cillustrate that the needle capture devices 136 a, 138 a can residewithin the foot 106 a distance from the tissue location surface 144.Needle receiving lumens or funnels 162 can extend from the tissuelocation surface 144 to the needle capture devices 136 a, 138 a. Thefunnels 162 can have a diameter at the tissue location surface 144 thatis larger than the diameter of the needle capture devices 136 a, 138 a.The diameter can then taper as the funnels extend toward the needlecapture devices 136 a, 138 a. One will appreciate in light of thedisclosure herein that the funnels 162 can thus guide the needles intothe needle capture devices 136 a, 138 a in the event that they areslightly deflected out of alignment when passing through tissue.

Additional or alternative implementations, as illustrated in FIG. 9A, inlieu of or in addition to the exit slot, a suturing device 100 a′ caninclude a foot 106 a′ that has a retaining channel 162′, which house thesutures 140. After engaging the suturing device 100 a′ with the vesselwall, and connecting the needles with needle capture devices, thesutures 140 can be pulled out of the retaining channel 162′.Furthermore, in at least one implementation, the sutures 140 can bepositioned on the outside of the foot 106 a′ (i.e., the foot may nothave any channels or retaining slots therein). In other words, asillustrated in FIG. 9B, the sutures 140 may spill over the side of thefoot 106 a′.

In addition, although in some implementations the foot 106′ may have anapproximately circular cross-sectional shape (e.g., the shape at thetissue location surface 144 (FIG. 8C), the shape of the foot may varyfrom one implementation to another. For instance, as illustrated in FIG.9C, the suturing device can incorporate a foot 106 a″ of a suturingdevice 100 a″. The foot 106 a″ may have an oval cross-sectional shape.It should be appreciated, however, that the foot can have any number ofsuitable shapes.

While the implementations described hereinabove included passive tissueports or non-articulating foot, the present invention is not so limited.As previously mentioned, implementations of the present invention canalso include suturing devices with an articulating foot or non-passivetissue ports. Such implementations can include a foot that articulatesbetween a pre-deployed configuration and deployed configuration. In thepre-deployed configuration the tissue ports can be at least partiallyclosed. In the deployed configuration the tissue ports can be open. Forexample, in one implementation the foot can be distally displaced fromthe shaft when in the deployed configuration, thereby opening tissueports between the foot and the shaft. In implementations including anarticulating foot, the foot can be used to draw or push tissuesurrounding an opening in a body lumen to be repaired into the tissueports.

For example, FIGS. 10A-11B illustrate perspective view of a suturingdevice 300 with an actuating foot 106 a in accordance with animplementation of the present invention. The suturing device 300 caninclude a body 102 a comprising a proximal portion or shaft 104 a and adistal portion or foot 106 a. FIGS. 10A-12B further illustrate that thesuturing device 300 can include a flexible, guidebody 109 a extendingdistally from the end of the foot 106 a. The foot 106 a can include aflared portion that extends radially outward of the guidebody 109 a. Theshaft 104 a can include a proximal end 108 and a distal end 110. Ahandle 112 a can be secured to the proximal end 108 of the shaft 104 a.The handle 112 a can be of sufficient dimensions to allow a medicalpractitioner to grasp the handle 112 a and use it to manipulate thesuturing device 300 during use. Furthermore, the handle 112 a cansupport a needle actuation handle 114 a.

Similar to the suturing device 100, the suturing device 300 can includeone or more needles 122, 124 secured to the needle actuation handle 114a. The needle actuation handle 114 a can be sized to be positionedwithin a receptacle extending into the proximal end of the handle 112 a.The needle actuation handle 114 a can allow a medical practitioner toadvance the needles 122, 124 into the shaft 104 a and foot 106 a. Inparticular, the shaft 104 a can include one or more needle lumens 126,128 extending from the proximal end 108 to the distal end 110 of theshaft 104 a. The needle lumen 126, 128 can guide the needles 122, 124from the proximal end 108 of the shaft 104 a, through the shaft 104 a,and into the foot 106 a.

Additionally, the foot 106 a can include one or more needle capturedevices. For example, FIGS. 10B and 11B illustrates that the foot 106 acan include a first needle capture device 136 and a second needlecapture device 138, each removably secured within a tissue locationsurface 144 of the foot 106 a. Each needle capture device 136, 138 cancorrespond to and be aligned with a needle lumen 126, 128. Referring nowto FIG. 11C, the suturing device 100 a can include retaining slots 161 aconfigured to allow the foot 106 a to receive and retain therein needlecapture devices 136, 138.

The needle capture devices 136, 138 can be secured to a suture 140removably stored within the foot 106 a and/or guidebody 109 a. Forexample, a length of suture 140 can have its ends secured to the firstand second needle capture devices 136, 138. As previously mentioned, theneedle capture devices 136, 138 can be configured to receive and securethe needles 122, 124 to the suture 140. In particular, once the needles122, 124 are advanced into the needle capture devices 136, 138, theneedle capture devices 136, 138 can lock the needles 122, 124 therein.Thereafter, when the needles 122, 124 are retracted from the foot 106 aand the shaft 104 a, the needles 122, 124 can pull the proximal ends ofthe suture 140 from the foot 106 a, through the needle lumens 126, 128and out of the proximal end 108 of the shaft 104 a.

As shown by FIG. 11C, the suture 140 can extend from the needle capturedevices 136, 138, out of retaining slots 161 a, along the outer wall ofthe foot 106 a, and into the guidebody 109 a via suture exit slot 160 a.As the needles 122, 124 are retracted from the foot 106 a and the shaft104 a, the distal portion or loop of the suture 140 can be pulled fromthe guidebody 109 a and foot 106 a. In particular, as the suture 140 ispulled proximately, the suture 140 can exit the guidebody 109 a and foot106 a via the suture exit slot 160 a and retaining slots 161 a. Once thesuture 140 has been pulled from the guidebody 109 a and foot 106 a, thesuturing device 300 can be proximately withdrawn from the patient. Asshown in FIG. 11C, the suture exit slot 160 a can extend generallyradially outward from the center of the guidebody 109 a. The radialconfiguration can help ensure that the suture exit slot 160 a does notcatch or pull on tissue as the suturing device 300 is withdrawn.

The suturing device 300 can further include a foot actuator mechanism302. As shown in FIGS. 10A-11B, a medical practitioner can slide thefoot actuator mechanism 302 distally toward the foot 106 a, therebycausing the foot 106 a to be distally displaced from a firstconfiguration (FIGS. 10A-10B) in which the foot 106 a abuts against thedistal end 110 of the shaft 104 a and a deployed configuration (FIGS.11A-11B) in which the foot 106 a is distally separated from the distalend 110 of the shaft 104 a.

As shown by FIGS. 11A-11B, by actuating the foot 106 a into the deployedconfiguration, a tissue port 118 b can be opened up between the foot 106a and the shaft 104 a. As discussed previously, the tissue port 118 bcan receive tissue surrounding body lumen opening to be closed using thesuturing device 300. As shown in FIGS. 11A-11B, when in the deployedconfiguration the foot actuator mechanism 302 can distally displace aspinal member 116 b within the shaft 104 a, thereby distally displacingthe foot 106 a secured, which may be secured to the spinal member 116 b.Thus, the spinal member 116 b can help define the tissue port 118 b.

The foot actuator mechanism shown in FIGS. 10A and 11A comprises a tab302 directly secured to the spinal member 116 b. In suchimplementations, the foot actuator mechanism 302 can the medicalpractitioner with tactile feedback on how far the foot 106 a has beendeployed. In particular, in some implementations the distance the footactuator mechanism 302 slides distally within the handle 112 a can havea 1:1 ratio with respect to the distance the foot 106 a separates fromthe distal end 110 of the shaft 104 a. In alternative implementations,the distance the foot actuator mechanism 302 slides distally within thehandle 112 a can have a 2:1 ratio, a 3:1, a 4:1 ratio, or a greaterratio with the distance the foot 106 a separates from the distal end 110of the shaft 104 a. In yet further implementations, the distance thefoot actuator mechanism 302 slides distally within the handle 112 a canhave a 1:2 ratio, a 1:4 ratio, or a smaller ratio with respect to thedistance the foot 106 a separates from the distal end 110 of the shaft104 a.

A wide variety of foot actuation mechanisms can be employed to move thefoot 106 a between the first configuration (FIGS. 10A-10B) and thedeployed configuration (FIGS. 11A-11B). The tab 302 illustrated in FIGS.10A and 11A is only one example of such a mechanism. In additionalimplementations, the foot actuation mechanism can include a handle thatpivots from a position generally perpendicular to the central axis ofthe handle 112 a to a position generally parallel to the central axis ofthe handle 112 a. In yet further implementations, the foot actuationmechanism can include a handle secured to the spinal member 116 b thatis positioned between the handle 112 a and the needle actuation handle114 a. In such implementations, the medical practitioner can depress thefoot actuation mechanism handle at least partially within the handle 112a to deploy the foot 106 a. The medical practitioner can then depressthe needle actuation handle 114 a at least partially within the footactuation mechanism handle to deploy the needles 122, 124.

In any event, once the foot 106 a is deployed (FIGS. 11A-11B) themedical practitioner can proximally withdraw the foot 106 a until itabuts against the inner wall of a body lumen to be closed. After which,the medical practitioner can compress the foot 106 a and the shaft 104 atogether thereby urging or pushing tissue into the tissue port 118 b.Thus, the articulating foot 106 a can function to help ensure thattissue surrounding an opening to be closed is properly positioned withinthe tissue port 118 b prior to deployment of the needles 122, 124.

In some implementations, the foot actuation mechanism 302 can be biasedtoward the first configuration (FIGS. 10A-10B). For example, FIG. 10Aillustrates that the suturing device 300 can include a biasing member318 configured to bias the foot actuation mechanism 318 toward theproximal end of the handle 112 a. FIG. 10A illustrates that the biasingmember 318 can comprise a leaf string. In alternative implementations,the biasing member 118 can include an elastomeric projection, or otherstructure that provides biasing characteristics similar to a spring,including, for example, a torsion spring, or a twin spring. One willappreciate in light of the disclosure herein that the biasing member 318can cause the foot 106 a to automatically move from the deployedconfiguration (FIGS. 10A-10B) toward the first configuration (FIGS.11A-11B) upon release of the foot actuation mechanism 302. Thus, thebiasing member 318 can cause the foot 106 a to automatically capturetissue and urge the tissue into the tissue port 118 b once the tissuelocation surface 144 is abutted against the inner wall of the bodylumen, and the foot actuation mechanism 302 is released. In alternativeimplementations, the foot actuation mechanism 302 may not include abiasing member, and the actuation of the foot 106 a can be a manualprocedure performed by the medical practitioner.

In some implementations of the present invention, the suturing device300 can include a locking mechanism configured to releasably lock thefoot 106 a in one or more configurations, such as, for example, thefirst or pre-deployed configuration, the deployed configuration, or aposition between the first and deployed configurations. For instance,the locking mechanism can lock the foot 106 a, and the foot actuationmechanism 302, in the deployed configuration (FIGS. 10A-10B) to ensurethat the foot 106 a is not compressed toward the shaft 104 a, or viceversa, until the foot location surface 144 is positioned against theinner wall of a body lumen to be repaired. Alternatively oradditionally, the locking mechanism can releasably lock the foot 106 ain place relative to the shaft 104 a once tissue has been captured inthe tissue port 118 b. This can help ensure that the foot 106 a and theshaft 104 a pinch or otherwise hold the tissue surrounding an opening tobe repaired until the medical practitioner can deploy the needles 122,124.

For example, FIGS. 12A and 12B illustrate one implementation of a footactuation mechanism that includes a locking mechanism 324. Specifically,FIGS. 12A and 12B illustrate that the locking mechanism 324 can includea button 320 and one or more protrusions 322. Specifically, in theillustrated implementation, the foot actuation mechanism 302 a includesa button 320. When the button 320 is in the decompressed position shownin FIG. 12A, the foot actuation mechanism 302 a, and the foot 116 a, canfreely move relative to the handle 112 a and/or shaft 104 a.Alternatively, when the button 320 is in the compressed position shownin FIG. 12B, one or more protrusions 322 may extend out from the footactuation mechanism 302 a. When extended, the one or more protrusions322 may engage corresponding grooves (not shown) located within thehandle 112 a, thereby locking the foot actuation mechanism 302 a and thefoot 106 a relative to the handle 112 a and/or shaft 104 a. Thus, thelocking mechanism 324 can allow a medical practitioner to lock the foot106 a in one or more positions relative to the shaft 104 a.

In order to release the locking mechanism 324, the medical practitionercan decompress the button 320, thereby withdrawing the one or moreprotrusions 322 into the foot actuation mechanism 302 a. When in thedecompressed position, the foot actuation mechanism 302 a, and the foot116 a, can freely move relative to the handle 112 a and/or shaft 104 a.

In additional implementations, the suturing devices can include lockingmechanisms having other configurations. For example, such lockingmechanisms can include spring-loaded tabs (not shown) that extend intothe housing 112 a or shaft 104 a from the foot actuation mechanism. Suchspring-loaded tabs can prevent actuation of the foot 106 a unlessdeactivated by compressing a button or other release mechanism similarto the button 320.

In some implementations of the present invention, the suturing device300 can include both a biasing member 318 and a locking mechanism 324.Alternatively, the suturing device 300 can include one of a biasingmember 318 and a locking mechanism 324, or neither a biasing member 318or a locking mechanism 324. One will appreciate that the inclusion ofthe biasing member 318 and/or locking mechanism 324 can be based on amedical practitioner's preference.

Referring again to FIGS. 10A-11A, the suturing device can include a footposition indicator lumen 308 (FIGS. 13A-13I) that extends distally froma position port 310 to position indicator 312 located on the shaft 104a. When the foot 106 a is properly positioned for deployment within ablood vessel or other body lumen (i.e., the tissue location surface 144is completely within the body lumen), blood pressure can cause blood toflow into the position port 310, proximally through the indicator lumen308 (FIGS. 13A-13I) to the position indicator 312.

As shown in FIGS. 10A-11B, the position indicator may optionallycomprise a window 312 in which blood within the indicator lumen may bevisible. In particular, FIGS. 10A-11B illustrate that the shaft 104 a(or in alternative implementations the handle 112 a) can include a clearwindow 312. In further implementations, the position indicator cancomprise a length of the indicator lumen 308 that extends outside of theshaft 104 a or handle 112 a through which blood can flow out, indicatingto the medical practitioner that the foot 106 a is properly positioned.In yet further implementations, the position indicator can includeelectrical pressure sensors, electrolytic fluid detectors, or the like.

In additional implementations, the foot 106 a or the distal portion ofthe shaft 104 a can include a radiopaque material to increase visibilityduring placement. Optionally, the radiopaque material can be a layer orcoating any portion of the foot 106 a or shaft 104 a. The radiopaquematerials can be platinum, tungsten, silver, stainless steel, gold,tantalum, bismuth, barium sulfate, or a similar material.

It is further contemplated that the external surface and/or internalsurface of the devices or members (e.g., exterior and luminal surfaces)as well as the entire body can be coated with another material having acomposition different from the primary material. The use of a differentmaterial to coat the surfaces can be beneficial for imparting additionalproperties to the device or member, such as providing radiopaquecharacteristics, drug-reservoirs, and improved biocompatibility.

In one embodiment, at least one biocompatible polymeric layer can be acoating that is applied over the entire suturing device 300, or toselect portions. Examples of such biocompatible polymeric materials caninclude a suitable hydrogel, hydrophilic polymer, hydrophobic polymerbiodegradable polymers, bioabsorbable polymers, and monomers thereof.Examples of such polymers can include nylons, poly(alpha-hydroxyesters), polylactic acids, polylactides, poly-L-lactide,poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids,polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide,polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides,polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones,polyesters, polyanydrides, polyphosphazenes, polyester amides, polyesterurethanes, polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols,polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcoholcopolymers, ethylenevinylalcohol copolymers (EVAL),propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP),combinations thereof, polymers having monomers thereof, or the like.Additionally, the coating can include hydrophilic and/or hydrophobiccompounds, polypeptides, proteins, amino acids, polyethylene glycols,parylene, heparin, phosphorylcholine, or the like.

The coatings can also be provided on the suturing device 300 or portionthereof to facilitate the loading or delivery of beneficial agents ordrugs, such as therapeutic agents, pharmaceuticals and radiationtherapies. As such, the material and/or holes can be filled and/orcoated with a biodegradable material.

FIGS. 10A-11A further illustrates that the suturing device 300 caninclude one or more balloons 304 secured to the foot 106 a. The balloons304 can be inflated by sending air or another fluid into a balloon lumen306 extending from the shaft 104 a into the foot 106 a (e.g., aconnector, such as a luer, can be couple to a proximal end of theballoon lumen 306 to allow connection to a fluid source). Once inflated,the balloons 304 can effectively increase the surface area of the tissuelocation surface 144 and aid in locating the tissue surrounding anopening in a body lumen to be closed, as explained in greater detailbelow. One will appreciate that a medical practitioner can inflate theballoons 304 after receiving an indication from the position indicator312 that the foot 106 a is in a position ready for deployment. Inparticular, the balloons 304 can be inflated prior actuating the footactuator mechanism 302 to deploy the foot 106 a or after deploying thefoot 106 a.

In any case, the balloons 304 can help ensure that the foot 106 a cannotbe proximally withdrawn back through the body lumen when the foot 106 aand shaft 104 a are compressed together to draw tissue into the tissueport 118 b. One will appreciate that the balloons 304 can provide theaforementioned functions without dilating or otherwise damaging theopening in the body lumen to be closed. In particular, because theballoons 304 can be deflated prior to passing the foot 106 a distally orproximally through the body lumen, the balloons 304 can avoid damagingthe tissue surround the opening of a body lumen to be closed.

FIGS. 13A-13I illustrate one implementation of a method of using thesuturing device 300 to close an opening 210 in a body lumen 200. Themethod can include inserting the suturing device 300 in a distaldirection into the body lumen 200. This can be accomplished with orwithout the use of a guidewire. FIGS. 13A-13I illustrate an example inwhich a guidewire 202 is used. It should be appreciated that, althoughthe tissue tract 208 is illustrated at approximately 90° relative to thebody lumen, the tissue tract 208 can be oriented at any number ofsuitable angles, which can vary from one embodiment to the next. Forexample, the tissue tract 208 can be oriented at a 45° relative to thebody lumen 200.

As shown by FIG. 13A, the guidewire 202 may enter the body lumen 200through an opening or puncture site 210 formed in the body lumen wall212. The guidewire 202 may extend along the body lumen 200. Asillustrated by FIGS. 13A-13B, the flexible guidebody 109 a and theguidewire lumen 134 can be advanced over the guidewire 202 in a monorailfashion, so that the guidewire 202 helps direct the suturing device 300along the tissue tract 208 into the body lumen 200 through the opening210.

As shown by FIGS. 13A-13B, the suturing device 300 can be slowlyadvanced until the position port 310 passes by the body lumen wall 212.Once past the body lumen wall 212, blood pressure can cause blood toflow into the position port 310, proximally through the indicator lumen308 to the position indicator (FIGS. 10A-11B). In alternativeimplementations, blood can pass out of the end of the indicator lumen308, notifying the medical practitioner that the foot 106 a is in aposition within the body lumen 202, and is ready for deployment.

When the foot 106 a is positioned within the body lumen 202, the medicalpractitioner can slide the foot actuation mechanism 302 distally alongthe handle 112 a (FIGS. 10B and 11B), thereby causing the foot 106 a todistally separate from the distal end 110 of the shaft 104 a, as shownby FIG. 13C. In other words, the foot 106 a can be articulated from afirst configuration, in which the tissue location surface 144 of thefoot 106 a is abutted against the distal end 110 of the shaft 104 a, toa deployed position, in which the tissue location surface 144 of thefoot 106 a is distally separated from the distal end 110 of the shaft104 a. As illustrated by FIG. 13C, by deploying the foot 106 a, a tissueport 118 b can be opened between the foot 106 a and the shaft 104 a.Once in the deployed position, the medical practitioner can compress alocking mechanism 324 (FIGS. 12A and 12B) to lock the foot 106 arelative to the shaft 104 a.

As shown by FIG. 13D, the medical practitioner can optionally inflatethe one or more balloons 304. The balloons 304 can effectively increasethe surface area of the tissue location surface 144 of the foot 106 a.The medical practitioner can then slowly retract the suturing device 300until resistance is felt when the tissue location surface 144 and/or theballoons 304 abut against the inner surface of the body lumen wall 212.By so doing, the distal end 110 of the shaft 104 a can pass back throughthe opening 210 in the body lumen wall 212.

Once the shaft 104 a is located on the proximal side of the body lumenwall 212, and the foot 106 a is positioned on the distal side of thebody lumen wall 212, the tissue 214 of the body lumen wall 212 adjacentthe opening 210 can at least partially rebound or otherwise extend intothe tissue port 118 b, as shown by FIG. 13D. At this point, with thefoot 106 a locked in place, the medical practitioner can disengage thelocking mechanism 324 (FIGS. 12A-12B). After the locking mechanism 324is disengaged, the biasing member 318 (FIG. 10A), if included, can drawthe shaft 104 a and the foot 106 a together. Otherwise, the medicalpractitioner can manually draw the shaft 104 a and the foot 106 atogether using the foot actuation mechanism 302. The action of the foot106 a and the shaft 104 a compressing toward each other can draw thetissue 214 further into the tissue port 118 b, as depicted in FIG. 13E.In other words, the distal surface 110 of the shaft 104 a and the tissuelocation surface 144 of the foot 106 a can draw or push the tissue 214into the tissue port 118 b toward the spinal member 116 b.

Next the medical practitioner can optionally lock the foot 106 a inplace relative to the shaft 104 a using the locking mechanism 324 (FIGS.12A and 12B). If the suturing device 300 includes a biasing member 318,the foot 106 a may not be locked in place at this point. In any event,once the tissue 214 is positioned within the tissue port 118 a, theneedles 122, 124 can be deployed as shown in FIG. 13F. In particular,needles 122, 124 can be advanced in a distal direction within the needlelumens 126, 128, out of the needle exit openings 130, 132, distallyacross the tissue port 118 a through the tissue 214, and into the needlecapture devices 136, 138, as indicated by the arrows of FIG. 13F. Thiscan be done by pushing the needle actuation handle 114 a into the handle112 a (FIGS. 10A and 11A). The needles 122, 124 and needle capturedevices 136, 138 can then be withdrawn out of the foot 106 a, proximallyacross the tissue port 118 b through the tissue 214, and out of theproximal end suturing device 300, as depicted by the arrows in FIG. 13G.One will appreciate that withdrawing the needles 122, 124 and needlecapture devices 136, 138 can at least partially withdraw the proximalends of the suture 140 from the foot 106 a, allowing the ends of thesuture 140 to be retrieved by the medical practitioner.

Furthermore, as shown by FIG. 13G, as the needles 122, 124, arewithdrawn, the distal end of the suture 140 (i.e., the suture loop) canbe pulled from the guidebody 109 a and foot 106 a via the suture exitslot 160 a.

At this point, or before or after, if desired, the medical practitionercan withdraw the guidewire 202 from the body lumen 200 and the suturingdevice 300, as shown by FIG. 13H. FIG. 13H illustrates that the suturingdevice 300 can then be withdrawn from the body lumen 200 and out of thetissue tract 208. The medical practitioner can articulate the foot 106 afrom the deployed position to the first position using the footactuation mechanism 302 either before or during the withdrawal of thesuturing device 300. Once the suturing device 300 has been removed, thesuture 140 can be employed to close the opening 210 in the body lumen200, as shown by FIG. 13I. In particular, a surgical knot 158 can betied thereby closing the opening in the body lumen 200.

In one or more embodiments, the foot of the suturing device may beinterchangeable and may be selected and coupled to a particular shaftbased on the size of the opening in the body lumen that is intended tobe closed. Thus, the user can select a suitable foot that correspondswith the opening in the body lumen. For example, a larger sized foot maybe selected for closing larger openings, and a smaller sized foot can bechosen for closing smaller openings in the body lumen.

The larger sized foot can have tissue ports located or formed thereonsuch that the tissue surrounding the larger opening may be capturedwithin the tissue ports. For instance, the tissue ports of the largerfoot may be located at an appropriate distance from the center axis ofthe suturing device, such as to correspond with the dimensions of theopening that is intended to be closed by the suturing device. Similarly,the smaller sized foot may have tissue ports that accommodate capturingthe tissue surrounding the smaller openings in the body lumen.Additionally, the needle capturing devices, located in the foot of thesuturing device, may be positioned at an appropriate distance from thecenter axis of the suturing device, such that the needle capturingdevices are located over the tissue surrounding the opening, and theneedles may pass through the tissue and into the needle capturingdevice.

Moreover, while the foot of the suturing device may be interchangeableto accommodate closure of a particular sized opening in the body lumen,in some embodiments, the shaft of the device may remain unchangedirrespective of the particular foot that is being used. The shaft may beadjusted to correspond with the particular foot being used in thesuturing device. More specifically, the needle lumens of the shaft maybe adjusted and/or may be moved to a position that would allow theneedles to exit the needle lumens and pass through the tissue.Furthermore, after adjusting the shaft, the needles can be aligned withthe needle capture devices located in the corresponding foot. Forexample, adjusting the shaft can include moving the needle exit openingsoutward, so the needles exit the shaft at locations that allow theneedles to couple with the needle capture devices.

In further embodiments, the suturing device may include a guide memberthat secures the foot. The guide member can be slidably positionedwithin the shaft. Thus, the foot can move together with the guidemember, as the guide member slides or moves relative to the shaft of thesuturing device. The user may position the guide member and at least aportion of the foot in the opening of the body lumen, such that the footand/or the guide member can capture at least a portion of the tissuesurrounding the opening.

In some embodiments, the needles can be housed in the shaft, asdescribed above. However, the guide member also may house the needlesand at least a portion of the suture. Thus, the needles located in theguide member can be advanced proximally, toward the shaft and can enterneedle lumens in the shaft. Furthermore, the foot may have one or morechannels or lumens that can guide the needles from the guide member andtoward the needle openings (leading up to the needle lumens) in theshaft.

Referring now to FIG. 14 which illustrates one embodiment of a suturingdevice 400 that incorporates an interchangeable foot. The suturingdevice 400 may be substantially the same as any one of the suturingdevices 100, 100 a, 300 (FIGS. 1-13I), and combinations thereof, exceptas described below. The suturing device 400 may have a body 402 thatincludes a shaft 404 and an interchangeable foot 406. As noted above,the foot 406 can be removable and replaceable. The foot 406 also can bechosen by the user based on the size of the opening in the body lumenthat is intended to be closed.

The shaft 404 may have a proximal end 408 and a distal end 410, theproximal end 408 being closer to the user of the suturing device 400.Additionally, the suturing device 400 can have a handle 412, which canhelp the user to grasp and hold the suturing device 400 during theoperation thereof. The suturing device 400 also may have an actuationhandle 414 that may actuate the suturing device 400 (e.g., by engagingthe needles with the needle capture devices, as further describedbelow).

In some embodiments, as noted above, the foot 406 is coupled to a guidemember 416. The guide member 416, in turn, may be slidably locatedwithin the shaft 404. Accordingly, the foot 406 may move together withthe guide member 416 relative to the shaft 404. For instance, the footand the guide member can move in a distal and/or proximal directionalong the center axis of the shaft 404.

Furthermore, the user may select an appropriately sized foot 406, forexample, based on the size of the opening in the body lumen. Thus,suturing device 400 can have an interchangeable foot 406, such that thefoot 406 of a first size may be selected, coupled to, and/or removedfrom the guide member 416. The foot 406 also may be substituted foranother foot of a different size and/or shape. Similarly, the foot 406and the guide member 416 (as a coupled pair or a single unit) may beselected and exchanged as the single unit. In any case, the user maychoose and/or replace a previously chosen foot 406, such that the foot406 is appropriately sized relative to the opening in the body lumen.

The foot 406 can have one or more tissue ports 418, which can accepttissue surrounding the opening in the body lumen. As described above,the size of the foot 406 can be selected based on the size of theopening that is intended to be closed. Hence, the size, locations, andshapes of the tissue ports 418 may correspond with a particular size ofthe opening. In other words, the tissue ports 418 can be sized such thattissue surrounding the opening fits within the tissue ports 418.

In some embodiments, the shaft 404 can house multiple needles, such asneedles 430, 432. The 430, 430 can pass through the tissue ports 418,thereby passing through the tissue surrounding the opening. To allow theneedles 430, 432 to pass through the tissue ports 418, the foot 406 canhave clearance slots (or holes) 419.

In one or more embodiments, the shaft 404 can have multiple leafs 448,which can be located near the distal end 410 of the shaft 404. Forexample, the shaft 404 can have multiple slots 405, which can divide orsection the distal portion of the shaft 404, thereby forming multipleleafs 448. As further described below, the leafs 448 can flex outwardthereby flexing the needles 430, 432 to a predetermined angle. As such,the user can adjust the size of the shaft 404 by flexing the leafs 448,such as to facilitate closure of an opening of a particular size. Theleafs 448 also can flex inward (i.e., substantially back to theiroriginal positions).

Moreover, the shaft 404 also may have different configurations, whichmay depend on the particular foot 406 that is used. For instance, asillustrated in FIG. 15A, a suturing device 400 a can have a shaft 404 athat can be used together with a foot 406 a. Similar to the suturingdevice 400 (FIG. 14), the suturing device 400 a may be substantially thesame as any one of the suturing devices 100, 100 a, 300, andcombinations thereof (FIGS. 1-13I), except as described below. In someembodiments, the suturing device 400 a can have a guide lumen 420 thatcan be configured to accept the guide member 416.

Specifically, the guide lumen 420 may be sized such that guide member416 can freely slide in the proximal and/or distal direction along alength of the guide lumen 420 (i.e., the guide member 416 can have aslip fit within the guide lumen 420). In some embodiments, at least aportion of the guide lumen 420 can have a clearance (e.g., approximately0.005″) between the outside wall of the guide member 416 and the wall ofthe guide lumen 420. It should be noted that the clearance can vary fromone embodiment to another.

Also, in one or more embodiments, at least a portion of the guide lumen420 can have friction or interference fit with the guide member 416. Forexample, an interference-fit portion 421 of the guide lumen 420 can havean interference fit, while a slip-fit portion 422 can have a slip fitwith the guide member 416. Consequently, the user may force the guidemember 416 along the guide lumen 420, such that the guide member 416slides along the guide lumen 420 when the user applies a force thereto.When the user stops applying force to the guide member 416, however, theguide member 416 may remain fixed within the guide lumen 420. Thelengths of the interference-fit portion 421 and/or the slip-fit portion422 may vary from one implementation to another.

In some implementations, the length of the interference-fit portion 421or of the slip-fit portion 422 may be the same as the length of theguide lumen 420. Furthermore, the clearance between the guide member 416in the guide lumen 420 along the slip fit portion 422 can vary and canbe greater or less than 0.005″. Accordingly, the ease of movement or theamount of force necessary to move the guide member 416 along the guidelumen 420 also can vary from one embodiment to another.

Additionally or alternatively, the suturing device 400 a can include aclip or clamp that can secure the guide member 416 to the shaft 404 a,to prevent relative movement thereof. Also, the user can hold the guidemember 416 during the procedure, in order to keep the guide member 416and/or the foot 406 a stationary relative to the shaft 404 a. In anyevent, the guide member 416 and the foot 406 a can remain fixed at adesired position relative to the shaft 404 a.

Once the user selects an appropriately sized foot, such foot (e.g., thefoot 406 a) can be coupled to the guide member 416. For example, thefoot 406 a can have an attachment lumen 424 that can accept the guidemember 416. In at least one embodiment, the foot 406 a also may have oneor more snap-in features 426. The snap-in features 426 may correspondwith protrusions 428 on the guide member 416. Thus, the foot 406 a canslide over the guide member 416, such that the snap-in features 426 snapover the protrusions 428, thereby securely coupling the foot 406 a tothe guide member 416.

It should be appreciated that other implementations may include varioustypes of connections between the foot 406 a and the guide member 416,which may permanently or removably couple the foot 406 a to the guidemember 416. For example, the foot 406 a and the guide member 416 canhave corresponding locking tapers, such as the foot 406 a can be coupledand locked to the guide member 416. Additionally or alternatively, thefoot 406 a and the guide member 416 may form an interference fittherebetween, such that the foot 406 a is securely coupled to the guidemember 416. Moreover, in some instances, the foot 406 a may bepermanently bonded to the guide member 416, such as by gluing or weldingthe foot 406 a to the guide member 416.

The guide member 416 and, consequently, the attachment lumen 424 canhave a non-circular cross-sectional shape, which can radially orient thefoot 406 a relative to the shaft 404 a. In other words, thecorresponding cross-sectional shapes of the guide member 416 and theattachment lumen 424 may prevent the foot 406 a from rotating about theguide member 416. For instance, the guide member 416 can have anon-cylindrical shape (e.g., partially elliptical and partially circularshape, square, etc.), such that the foot 406 a can fit over the guidemember 416 only in a single, predetermined axial orientation. Similarly,the cross-sectional shape of the guide lumen 420 and of the attachmentlumen 424 can correspond with the cross-sectional shape of the guidemember 416. Thus, radial orientation of the shaft 404 a, foot 406 a, andguide member 416 can be fixed relative to each other.

Fixing the radial orientation of the foot 406 a (e.g., about the centeraxis of the suturing device) relative to the shaft 404 a can ensure thatthe needles can engage the needle capture devices located in the foot406 a. In other embodiments, the foot 406 a can be radially fixed withrespect to the shaft 404 a using various other connections. For example,as described above, the foot 406 a may be permanently coupled to theguide member 416. Accordingly, the foot 406 a may have a permanentradial orientation with respect to the guide member 416.

In one or more embodiments, the guide member 416 can extend past adistal end of the foot 406 a. Accordingly, the user can feed at least aportion the guide member 416 through the opening in the body lumen. Asthe guide member 416 is fed through the opening an into the body lumen,the foot 406 a can remain attached to and can move together with theguide member 416. In some instances, the foot 406 a may remain outsideof the patient's body, while the guide member 416 is initiallypositioned within the body lumen.

Additionally or alternatively, the suturing device 400 a also caninclude a guidewire (e.g., similar to the guidewire 202 (FIG. 7A)),which can pass through the guide member 416. Hence, first the guidewirecan be inserted through the opening and into the body lumen, and,subsequently, the guide member 416 together with the foot 406 a canslide over the guidewire and moved into position within the opening.Consequently, in some embodiments, the guide member 416 need not and maynot protrude past the distal end of the foot 406 a.

Similar to the suturing devices described above, in connection withFIGS. 1-13I, the suturing device 400 a also can include multipleneedles, such as needles 430, 432 coupled to the actuation handle 414.Such needles 430, 432 (more specifically, respective piercing ends 431,433 of the needles 430, 432) can engage and couple to correspondingneedle capture devices 434 a, 436 a. The needle capture devices 434 a,436 a can be similar to or the same as the needle capture devices 136,138 (FIGS. 3, 4). In some embodiments, the needle capture devices 434 a,436 a can be positioned substantially parallel to the center axis of thesuturing device 400 a. Alternatively, as described in more detail below,the needle capture devices 434 a, 436 a can be oriented on an anglerelative to the center axis. The needles 430, 432 can slide in theproximal and/or in the distal direction within corresponding needlelumens 438, 440, located in the shaft 404 a. Moreover, the needles 430,432 can exit the shaft 404 a at respective needle exit openings 439,441, which may be located at the distal end 410 a. In other words, theneedle lumens 438, 440 can terminate at the needle exit openings 439,441, at the distal end 410 a for the shaft 404 a.

The needle capture devices 434 a, 436 a can be connected to each otherby a length of suture 442. The length of suture 442 can be located inand/or secured to the foot 406 a (e.g., as described above in connectionwith FIGS. 1-13I). Thus, as the needles 430, 432 move in the proximaldirection, the length of suture 442 can be removed and/or detached fromthe foot 406 a. Moreover, after the length of suture 442 is removedand/or detached from the foot 406 a, the suturing device 400 a can beremoved from the opening in the body lumen, without interfering with thelength of suture 442.

The foot 406 a can have a distal end 444 and a proximal end 446 a. Insome embodiments, the distal end 444 can have a substantially conicalshape, which can facilitate entry of the foot 406 a into to the openingin the body lumen. In other embodiments, however, the distal end 444 ofthe foot 406 a can have other suitable shapes, such as semi-spherical,spherical tapered, etc. Hence, as noted above, the shape and size of thedistal end 444 of the foot 406 a can vary from one embodiment to thenext, which may depend on the shape and size of the opening in the bodylumen.

Similarly, the proximal end 446 a and the distal end 410 a also can havevarious shapes, which may correspond with each other. For instance, theproximal end 446 a can be substantially flat and can correspond with asubstantially flat distal end 410 a. In other embodiments, the proximalend 446 a and/or the distal end 410 a can have other suitable shapes.

Additionally, as described above, the foot 406 a can be fixed to theguide member 416. Accordingly, the user can move the foot 406 a withrespect to the shaft 404 a by moving the guide member 416. Similarly, asthe guide member 416 moves within the guide lumen 420, when the foot 406a is coupled to the guide member 416, the foot 406 a also can moverelative to the shaft 404 a, either in the proximal direction (i.e.,toward the user) or in the distal direction.

As also noted above, the guide member 416 can be secured at a desiredposition within the guide lumen 420. Thus, the foot 406 a can be securedat a desired position with respect to the shaft 404 a. For example, in apre-deployed configuration the proximal end 446 a of the foot 406 a canbe separated by a distance from the distal end 410 a of the shaft 404 a.By contrast, in the deployed configuration, the proximal end 446 a canabut the distal end 410 a. The foot 406 a can move toward the shaft 404a, such that the proximal end 446 a abuts the distal end 410 a, and thefoot 406 a can remain in such the (deployed) position. Thus, in theembodiment illustrated in FIG. 15A, in the deployed configuration, theflat proximal end 446 a can abut the flat distal end 410 a and thesuturing device 400 a can remain in such configuration. As the guidemember 416 moves in the distal direction, the proximal end 446 a canmove away from the distal end 410 a.

As the foot 406 a enters the opening in the body lumen, the tissuesurrounding the opening can be captured in the tissue ports of the foot406 a. In one embodiment, the foot 406 a can have multiple tissue ports,such as tissue ports 418 a′, 418 a″. In other embodiments, the foot 406a can have a single tissue port, which can receive and capturesubstantially all of the tissue surrounding the opening. For example,the tissue port can surround the entire perimeter of the foot 406 a.Additionally, (as described above) the foot 406 a can have clearanceslots 419 a′, 419 a″ that can allow the needles 430, 432 to pass throughthe tissue ports 418 a′, 418 a″.

The distal end of the shaft and the proximal end of the foot of thesuturing device also can have non-flat configurations. For instance, asillustrated in FIG. 15B, a suturing device 400 b can have shaft 404 bthat has a non-flat distal end 410 b. The suturing device 400 b may besubstantially the same as the suturing device 400 a (FIG. 15A), exceptas otherwise described herein. The suturing device 400 b can have a foot406 b that can have a proximal end 446 b. As described above, the shapeof the proximal end 446 b can correspond with the shape of the distalend 410 b.

More specifically, the foot 406 b can have the proximal end 446 b thathas a tapered (conical) shape. The distal end 410 b also can have atapered shape (e.g., a cone-shaped or a tapered cavity in the distal end410 b). The tapered shape of the proximal end 446 b can correspond withthe tapered shape of the distal end 410 b. For example, the taperedshapes of the corresponding proximal end 446 b and distal end 410 b canhave an approximately 45° angle. An at least one other embodiment,however, the distal end 410 b and of the proximal end 446 b can havelocking angle (e.g., 3° included angle) tapers, which can operate in asimilar manner as a luer fitting. Accordingly, when the proximal end 446b is pressed into the distal end 410 b, the proximal end 446 b can belocked inside of the distal end 410 b, thereby securing the foot 406 bto the shaft 404 b.

Alternatively, the angle of the tapered shapes of the distal end 410 band/or of the proximal end 446 b can be non-locking (e.g.,self-releasing angle). Consequently, in some embodiments the proximalend 446 b may not be locked inside of the distal end 410 b. However, theuser can secure the proximal end 446 b within or abutting the distal end410 b by securing the guide member 416 with respect to the shaft 404 b,as described above.

The shaft 404 b can have multiple leafs, such as the leaf leafs 448 b,which can move outward in response to the pressure applied by the taperof the proximal end 446 b on the taper of the distal end 410 b. In otherwords, as the proximal end 446 b moves deeper into the distal end 410 b,the leafs 448 b can flex outward to accommodate the proximal end 446 bwithin the distal end 410 a.

In at least one embodiment, the foot 406 b can have a stop surface,which can define the most proximal portion of the proximal end 446 b.The stop surface can determine the maximum depth of entry of theproximal end 446 b into the distal end 410 b. More specifically, thestop surface can bottom out on a corresponding limiting surface in thedistal end 410 b (not shown). Thus, as the stop surface presses againstthe limiting surface in the distal end 410 b, the proximal end 446 breaches a predetermined depth within the distal end 410 b.

Consequently, at a predetermined depth, the foot 406 b can flex theleafs 448 b outward by a predetermined amount. More particularly, theleafs 448 b can be flexed to form a predetermined angle therebetween andrelative to the center axis of the suturing device 400 b.

The suturing device 400 b also can include needle lumens 438, 440.Particularly, the needle lumens 438, 440 can guide the needles 430, 432toward the foot 406 b, as the user pushes the actuation handle 414 inthe distal direction. Furthermore, in some embodiments, needle lumenportions 454, 455 can be located within the leafs 448 b. Thus, when theleafs 448 b flex outward to a predetermined angle, the needle lumenportions 454, 455 also can flex outward to a predetermined angle.

As the needles 430, 432 move within the corresponding needle lumens 438,440 and enter the needle lumen portions 454, 455 located in the leafs448 b, the needles 430, 432 also can be at least partially flexed to apredetermined angle. Hence, the piercing ends 431, 433 can move towardand approach the foot 406 b at a predetermined angle (i.e., not parallelto each other). Accordingly, in one or more embodiments, the foot 406 bcan house needle capture devices 434 b, 436 b that are positioned at anangle 456 relative to each other and relative to the center axis of thesuturing device 400 b. More specifically, the angle 456 can be greaterthan zero (i.e., orientations of the needle capture devices 434 b, 436 bmay be non-parallel to each other).

Furthermore, the angle 456 can be the same as the angle formed betweenthe needles 430, 432, when the leafs 448 b flex outward to apredetermined angle. Thus, as the needles 430, 432 move through theportions 450, 454, the needles 430, 432 can align with the needlecapture devices 434 b, 436 b. Consequently, movement of the actuatorhandle 414 can move the needles 430, 432 in the distal direction, suchas to engage the needle capture devices 434 b, 436 b. Particularly, theneedles 430, 432 can pass through the clearance slots 419 a′, clearanceslots 419 a″, pass through the tissue ports 418 b′, 418 b″, pass throughthe tissue surrounding the opening (as described below), and enter theneedle capture devices 434 b, 436 b.

As noted above, the foot 406 b can be chosen at least in part based onthe size and/or shape of the opening in the body lumen. In at least oneembodiment, the suturing device 400 b can have the same shaft 404 b forclosing openings of different sizes, by choosing an appropriately sizedcorresponding foot 406 b. For example, a first size of the foot 406 bcan have a distal end 444 b sized and configured to enter the opening ofa first size. Likewise, the tissue ports 418 b′, 418 b″ can be sized andconfigured to receive the tissue surrounding the first size opening.Furthermore, the needle capture devices 434 b, 436 b also can be locatedsuch that before entering the needle capture devices 434 b, 436 b, thepiercing ends 431, 433 pass through the tissue surrounding the openingin the body lumen. Similarly, the foot 406 b of a second size can havethe distal end 444 b, tissue ports 418 b′, 418 b″, and the needlecapture devices 434 b, 436 b sized, configured, and located (asapplicable to each) in a manner that allows the piercing ends 431, 433to pass through the tissue surrounding the opening of a second size, andenter the needle capture devices 434 b, 436 b.

Thus, on the first size foot 406 b, the stop surface 452 can be locatedat a first position, which can allow the proximal end 446 b to enterinto the distal end 410 b and flex the leafs 448 b and, consequently,the needle lumen portions 454, 455 to a first predetermined position(i.e., to a predetermined angle). The leafs 448 b and the needle lumenportions 454, 455 at the first predetermined angle can correspond withthe angle 456 of the first size foot 406 b. Accordingly, when thesuturing device 400 b that has the first size foot 406 b is in thedeployed configuration, and the proximal end 446 b is at its mostproximal position with respect to the distal end 410 b, the piercingends 431, 433 can enter and engage the needle capture devices 434 b, 436b.

Likewise, when the suturing device 400 b that has the second size foot406 b is in the deployed configuration, and the proximal end 446 b is atits most proximal position with respect to the distal end 410 b, thepiercing ends 431, 433 can enter and engage the needle capture devices434 b, 436 b. As noted above, the needle capture devices 434 b, 436 bcan be spaced farther apart from each other as compared with the firstsize foot 406 b. The locations of the needle capture devices 434 b, 436b and the angle 456 therebetween can correlate with the location of thestop surface 452, as the stop surface 452 can determine thepredetermined angle at which the needles 430, 432 can exit the needlelumens 440, 438. Furthermore, positions and angles of the needle capturedevices 434 b, 436 b and location of the stop surface 452 also cancorrelate with a particular size of the foot 406 b, and, morespecifically, with a particular size and shape of the distal end 444 b.In any event, the suturing device 400 b can accept the foot 406 b of anysize, in a manner that allows the piercing ends 431, 433 to engage theneedle capture devices 434 b, 436 b located in the foot 406 b of thatparticular size.

In some instances, the opening in the body lumen may have asubstantially circular shape. Hence, the suturing device can incorporatea foot that has circular or cylindrically shaped tissue ports.Furthermore, the foot of the suturing device also can have but is notlimited to a circular cross-section. For example, as illustrated in FIG.16A, the foot 406 can have a substantially circular shape (as notedabove the distal end of the foot 406 can be tapered or generally angled,to facilitate entry of the foot 406 and the tissue ports 418 into theopening).

Additionally, the foot 406 can have needle capture devices 434, 436located around the tissue ports 418, in a manner that the piercing endsof the needles can pass through the tissue surrounding the opening inthe body lumen, before entering the needle capture devices 434, 436. Inother words, locations of the needle capture devices 434, 436 as well aspositions thereof may depend on the particular size and shape of thefoot 406 and of the tissue ports 418, which can correspond with theparticular size and shape of the opening in the body lumen. In theembodiment illustrated in FIG. 16A, the foot 406 has two needle capturedevices 434, 436. One will appreciate, however, that this disclosure isnot so limited. More specifically, the foot 406 can have any number ofneedles capture devices positioned at different locations on the foot406, which may vary from one embodiment to another. Similarly, the shaftcan accommodate any number of needles that may correspond with theneedles capture devices on or in the foot 406. Furthermore, the foot 406can have a greater number of needles capture devices than the needleslocated in the shaft of the suturing device. In some embodiments, theguide lumen 420 also can have a substantially circular cross-sectionalshape, which can accept correspondingly sized and shaped guide member.

As noted above, the foot 406 also can have snap-in features 426 that cansecure the foot 406 to the guide member. In some instances it may bedesirable to remove the foot 406 from the guide number and/or to replacethe foot 406 with the foot 406 of a different size. In at least oneembodiment, the user can remove the foot 406 from the guide member bypressing on opposing sides of the foot 406, as illustrated with thearrows in FIG. 16B, such as to deform the foot 406. Particularly, thedeformation caused by the pressure applied along an axis approximatelyperpendicular to the axis on which the snap-in features 426 lie canforce the snap-in features 426 to move outward as indicated with thearrows. Consequently, as the snap-in features 426 move outward, thesnap-in features 426 also move away from the corresponding protrusionson the guide member, thereby releasing the foot 406 from the guidemember. Subsequently, the foot 406 can be removed from the guide numberand or replaced with another foot 406 (e.g., foot 406 of a differentsize and/or shape).

In some embodiments, the body of the suturing device can be adjustedindependent of the foot thereof. In other words, positions or angles ofthe leafs can be adjusted without having the proximal end of the footenter the distal end of the body. For example, FIGS. 17A-17B illustrateone embodiment of a suturing device 400 c that incorporates a shaft 404c, which can adjust angles of the leafs without having any portion of afoot 406 c enter the any portion of the shaft 404 c. It should be notedthat, except as otherwise described herein, the suturing device 400 cmay be substantially the same as the suturing device 400 a (FIG. 15A)and/or the same as the suturing device 400 b (FIG. 15B).

In some embodiments, the suturing device 400 c can include a dialadjustment 520 which can flex leafs 448 c outward. More specifically,the dial adjustment 520 can include a knob 522 connected to orintegrated with a threaded rod 524. Additionally, the dial adjustment520 can incorporate a wedge 526 that can be secured to or integratedwith a distal end of the threaded rod 524. The shaft 404 c can have athreaded channel 528 that can accept the threaded rod 524. Consequently,rotation of the threaded rod 524 can advance and retract the threadedrod 524 along the threaded channel 528 (as the threads of the threadedrod 524 and the threaded channel 528 mesh and interact with each other).

For example, the threaded rod 524 and the threaded channel 528 can haverespective right-handed external and internal threads. Thus, as thethreaded rod 524 rotates in a clockwise direction, the threaded rod 524can advance along the threaded channel 528 in the distal direction.Similarly, as the threaded rod 524 rotates in a counterclockwisedirection, the threaded rod 524 can advance along the threaded channel528 in the proximal direction. In other embodiments, the threaded rod524 and the threaded channel 528 can have respective left-handedexternal and internal threads. As such, rotation of the threaded rod 524in the clockwise direction can advance the threaded rod 524 in theproximal direction, while rotating the threaded rod 524 in thecounterclockwise direction can advance the threaded rod 524 in thedistal direction.

The wedge 526 can have a distal end 530 that may have a substantiallywedge-like shape or conical shape (i.e., a taper). Each of the leafs 448c also can have proximal ends 532 that have tapers, which can correspondwith the taper of the distal end 530. As the dial adjustment 520 movesin the distal direction, the distal end 530 can engage and press againstthe tapes of the proximal ends 532. Consequently, when the distal end530 presses against the proximal ends 532, the leafs 448 c can flexoutward (FIG. 17B).

In one or more embodiments, a top surface 533 of the shaft 404 c canhave markings that can correspond with one or more markings on the knob522 of the dial adjustment 520. Such markings can allow rotation of thedial adjustment 520 by a predetermined amount and/or to a predeterminedangular position. When the dial adjustment 520 rotates to apredetermined position, the wedge 526 can advance by a predeterminedamount toward the distal end of the shaft 404 c. Consequently, the wedge526 can push on the distal end 530 by a predetermined amount, therebyflexing the leafs 448 c to a predetermined angle. In other words, theleafs 448 c of the suturing device 400 c can be dialed to apredetermined angular position, thereby reconfiguring the suturingdevice 400 c into a deployed configuration.

As noted above, the predetermined angle of the leafs 448 c cancorrespond with the predetermined angle of needle capture devices 434 c,436 c located in the foot 406 c. Furthermore, locations and angle of theneedle capture devices 434 c, 436 c can be such as to allow the piercingends 431, 433 of the needles 430, 432 to enter and engage the needlecapture devices 434 c, 436 c. Also, locations and angle of the needlecapture devices 434 c, 436 c can be at least in part based on the sizeof the opening which is intended to be closed by the suturing device 400c.

In some embodiments, a proximal end 446 c can have an inward-facingtapered surface 534. Furthermore, the angle of the inward-facing taperedsurface 534 can correspond with the angle formed by the leafs 448 c andthe deployed configuration. For instance, surfaces 536 c, which definethe lowermost portion of the leafs 448 c, can be substantiallyperpendicular to the center axis of the shaft 404 c. Accordingly, as theleafs 448 c flex outward into the deployed configuration, the surfaces536 c can form an angle with respect to the center axis of the shaft 404c. Such angle may be a complementary angle of the predetermined angleformed by the leafs 448 c. Consequently, if the foot 406 c moves in theproximal direction, such that the inward-facing tapered surface 534comes into contact with the surfaces 536 c, the inward-facing taperedsurface 534 and the surfaces 536 c can seamlessly abut one another (FIG.17B).

Additionally, matching the inward-facing tapered surface 534 with thesurfaces 536 can help to further locate the foot 406 c relative to theshaft 404 c. Such locating can facilitate proper engagement of theneedles 430, 432 with the needle capture devices 434 c, 436 c. Asdescribed above, the foot 406 c can be moved in the proximal directionby moving the guide member 416 in the proximal direction. Furthermore,the foot 406 c also can have the snap-in features 426, which can snapabout the protrusions 428 of the guide member 416, thereby securing thefoot 406 c to the guide member 416.

In at least one embodiment, the guide member 416 can have an upperattachment lumen 424 c′ and a lower attachment lumen 424 c″. The upperattachment lumen 424 c′ can have a larger cross-section than the lowerattachment lumen 424 c″. Thus, the foot 406 c can be inserted over theguide member 416, such that the upper attachment lumen 424 c′ can passover the guide member 416, followed by the snap-in features 426 passingover and engaging the protrusions 428, and followed by the lowerattachment lumen 424 c″. In any event, the foot 406 c can be locatedabout the upper attachment lumen 424 c′ and/or about the lowerattachment lumen 424 c″.

Although the suturing devices described above provide the needles from aproximal portion of the device (i.e. from the body), and can move theneedles in the distal direction, it should be noted that this disclosureis not so limited. For instance, as illustrated in FIG. 18, a suturingdevice 400 d can have needles 430 b, 432 d that can move from the distalportion of the suturing device 400 d to the proximal portion thereof.Particularly, the suturing device 400 d can include a guide member 416 dthat can house the needles 430 d, 432 d.

Additionally, the guide member 416 d can house a cable 540. The cable540 can be connected to the needles 430 d, 432 d. Thus, when the cable540 moves in the proximal direction, the needles 430 d, 432 d also canmove and the proximal direction. The guide member 416 d is more fullydescribed in the U.S. Pat. No. 7,445,626, entitled “Device and Methodfor Suturing Tissue,” the entire content of which is incorporated hereinby reference.

Similar to the suturing device 400 b (FIG. 15B), the suturing device 400d can include a shaft 404 d and a foot 406 d. The foot 406 d can coupleto the guide member 416 d (in any number of ways, as described above).At least a portion of the guide member 416 d can be located in and/orpass through the shaft 404 d (i.e., through a guide lumen 420 d withinthe shaft 404 d). The shaft 404 d also can have needle lumens 438 d, 440d that terminate at first and second needle entrance openings 439 d, 441d.

In some embodiments, a proximal end 446 d of the foot 406 d can have atapered shape (similar to the proximal end 446 b of the foot 406 b (FIG.15B)). Moreover, a distal end 410 d of the shaft 404 d can have aninternal taper that can correspond with the taper of the proximal end446 d (similar to the suturing device 400 b (FIG. 15B)). Thus, theproximal end 446 d can enter the distal end 410 d, thereby spreadingleafs 448 d outward. Also, the leafs 448 d can be spread to apredetermined angle (as described above).

Needle lumen portions 454 d, 455 d can be located in the leafs 448 d.Hence, when the leafs 448 d flex to the predetermined angle, the needlelumen portions 454 d, 455 d also can flex to a predetermined angle,which can be the same as the predetermined angle of the leafs 448 d. Thefoot 406 d can include needle connector lumens 550, 552 which canchannel the needles 430 d, 432 d from the guide member 416 d and towardthe needle entrance openings 439 d, 441 d of the needle lumen portions454 d, 455 d, and, subsequently, through the needle lumens 438 d, 440 d.The needle connector lumens 550, 552 can be located at the samepredetermined angle as the needle lumen portions 454 d, 455 d, which canfacilitate seamless entry of the needles 430 d, 432 d into the needlelumen portions 454 d, 455 d.

Consequently, as the cable 540 moves in the proximal direction, theneedles 430 d, 432 d also can move in the proximal direction and canexit the guide member 416 d at corresponding needle exit openings.Subsequently, the needles 430 d, 432 d can enter the needle connectorlumens 550, 552 and can be guided toward the needle entrance openings439 d, 441 d of the needle lumens 438 d, 440 d. As the needles 430 d,432 d move further in the proximal direction, the needles 430 d, 432 dcan enter the needle lumen portions 454 d, 455 d, the needle lumens 438d, 440 d, and can exit the shaft 404 d at a proximal end thereof. Afterthe needles 430 d, 432 d exit the shaft 404 d, the user can grasp theneedles 430 d, 432 d and can entirely remove the needles from the shaft404 d.

In addition to the needles 430 d, 432 d, the guide member 416 d also canhouse the length of suture 442, opposing ends of which can be connectedto the needles 430 d, 432 d. As the needles 430 d, 432 d exit the guidemember 416, the needles 430 d, 432 d can pass through one or more tissueports (e.g., through tissue ports 418 d′, 418 d″). As noted above, thetissue surrounding the opening in the body lumen can enter tissue ports418 d′, 418 d″, after the foot 406 d of the suturing device 400 d entersthe opening.

As the needles 430 d, 432 d move out of the needle connector lumens, theneedles 430 d, 432 d can move together with the length of suture 442 andcan pass through the tissue ports 418 d′, 418 d″ and through the tissuesurrounding the opening, which can be positioned within the tissue ports418 d′, 418 d″. Thus, at least a portion of the length of suture 442 canpass through the tissue surrounding the opening in the body lumen. Inaddition to removing the needles 430 d, 432 d from the shaft 404 d, theuser also can remove the suturing device 400 d from the opening.Subsequently, the length of suture 442 can be used to close the opening.

Referring now to FIGS. 19A-19F; FIGS. 19A-19F illustrate an embodimentof a method of using the suturing device 400. It should be noted thatthe acts illustrated in FIGS. 19A-19F are equally applicable to all ofthe various embodiments of the suturing device, including but notlimited to the embodiments of suturing devices 400 a, 400 b, 400 c, 400d (FIGS. 15A-18). As illustrated in FIG. 19A, the guide member 416 canenter the body lumen 200 through the tissue tract 208 and then throughthe opening 210. More specifically, the tissue tract 208 can passthrough the patient's skin 204 and through the tissue 206. The tissuetract 208 can connect with the opening 210 that passes through the lumenwall 212 and into the body lumen 200. As noted above, the suturingdevice 400 can move along or together with the guide member 416 into theopening 210. Alternatively, a guidewire can pass through the guidemember 416 and into the body lumen 200, and the suturing device 400,together with the guide member 416, can move along the guidewire intothe opening 210.

As the guide member 416 enters the body lumen 200, the suturing device400 can be in the pre-deployed configuration. In other words, the leafs448 can be un-flexed or in a original position. Alternatively, as theguide member 416 enters the opening 210 in the body lumen 200, thesuturing device 400 can be in the deployed configuration, with the leafs448 flexed to the predetermined angle (the needles 430, 432 may be in aretracted position). Furthermore, in some embodiments, the proximal endof the foot 406 may be in contact with or separated from the distal end410 of the shaft 404.

As illustrated in FIG. 19B, after the guide member 416 enters the bodylumen 200, the foot 406 and the shaft 404 can move along or togetherwith the guide member 416 through the tissue tract 208. As the suturingdevice 400 moves through the tissue tract 208, the foot 406 can passthrough the lumen wall 212 and enter the opening 210. To the extent thatfoot 406 has a taper on the distal end thereof, such taper canfacilitate the entry of the suturing device 400 into the tissue tract208 and into the opening 210. Particularly, such taper can facilitateentry of the foot 406 into the opening 210.

As described above, the size and shape of the foot 406 can be chosen atleast in part based on the size and shape of the opening 210. In someembodiments, the size of the foot 406 can be such as to dilate theopening 210 to a desired size and/or shape, as the foot 406 enters theopening 210. For example, the foot 406 can dilate the opening 210 to adesired size for closing the opening 210. The tissue 214 surrounding theopening 210 can at least in part tear in response to the dilation causedby the foot 406. In other words, the dilation of the opening 210 can beachieved in part by elastic stretching and in part by tearing.

By choosing an appropriately sized and/or shaped foot 406, the finalsize of the opening 210 (i.e., the size of the opening after stretchingand/or tearing as the foot 406 passes into the body lumen 200) can becontrolled. Furthermore, the final size of the dilated opening 210 canbe such that would allow the needles 430, 432 to be deployed into thetissue surrounding the opening 210. Among other things, such dilationmay eliminate or reduce the risk of tearing the suture out of the tissue214 surrounding the opening 210 during the closure of the opening 210.It should be noted that tearing, including partial tearing, of thesuture out of the tissue 214 can result in an incomplete closure of theopening 210.

Additionally, as illustrated in FIG. 19C, the tissue 214 can contractwhen the foot 406 passes into the body lumen 200 such that the tissueports 418 can accept the tissue 214. Particularly, as the tissue 214enters the tissue ports 418, the tissue 214 can contract within thetissue ports 418 such as to overlap needle capture devices 434, 436. Inother words, the tissue 214 can close in around a center portion of thefoot 406 located within the tissue ports 418. As the foot 406 capturesthe tissue 214 within the tissue ports 418, the user may be able to feelthe resistance created by such capture to recognize that the suturingdevice 400 has reached a desired position for closing the opening 210.

In some embodiments, as the suturing device 400 passes through thetissue tract 208, the proximal end of the foot 406 can be pushed intothe distal end of the shaft 404 thereby spreading the leafs 448 outward(as indicated by the arrows). As the leafs 448 spread to a predeterminedposition, the suturing device 400 is reconfigured into the deployedconfiguration, as described above. The guide member 416 can be pulled inthe proximal direction. As the guide member 416 moves in the proximaldirection, the foot 406 also can move and the proximal direction therebyentering the distal end of the shaft 404 and spreading the leafs 448.Additionally, as noted above, the leafs 448 can remain spread outward toa predetermined angle for a desired period of time or for desired stepsor acts in the method of closing the opening in the body lumen 200.

Once the suturing device 400 is in the deployed position, the actuationhandle 414 can actuate the needles 430, 432 (as indicated by thearrows). More specifically, the handle 414 can move the needles 430, 432in the distal direction, toward the needle capture devices 434, 436. Asthe needles 430, 432 to pass through the needle lumen portions locatedin the leafs 448, the needles 430, 432 can flex out word to apredetermined angle which can match the angle of the needle capturedevices 434, 436. Consequently, the needles 430, 432 can engage andcouple to the needle capture devices 434, 436. Furthermore, when theneedles 430, 432 pass through the tissue ports 418, the needles 430, 432can enter and pass through the tissue 214. Hence, when the needles 430,432 engage the needle capture devices 434, 436, the needles 430, 432also can engage in pass through the tissue 214.

As illustrated in FIG. 19D, after the needles 430, 432 engage the needlecapture devices 434, 436, the needles 430, 432 can be withdrawn (i.e.,moved in the proximal direction), as indicated by the arrows. Thus, asthe needles 430, 432 are withdrawn and move in the proximal direction,the needle capture devices 434, 436 as well as the length of suture 442attached thereto can be pulled together with the needles 430, 432through the tissue 214. The length of suture 442 can detach from thefoot 406 and a portion of the length of suture 442 that is connected tothe needle capture devices 434, 436 can enter and pass through thetissue 214. Furthermore, needle capture devices 434, 436 and the lengthof suture 442 can enter and pass through the respective needle lumens438, 440 and or the proximal end of the shaft 404, exiting the needlelumens 438, 440 and the shaft 404.

Subsequently, as illustrated in FIG. 19E, the suturing device 400 can bewithdrawn from the opening in the body lumen 200 and from the tissuetract 208. More specifically, the shaft 404 and/or the guide member 416can move in the proximal direction, as indicated by the arrows. The useralso can pull the guide member 416 in the proximal direction, therebypulling on the foot 406 and on the shaft 404 and removing the suturingdevice 400 from the opening 210 and from the tissue tract 208.

In some embodiments, as the shaft 404 moves in the proximal direction,the distal end of the shaft 404 can separate from the proximal end ofthe foot 406, allowing the leafs 448 to contract or flex back to theiroriginal position, thereby reconfiguring the suturing device 400 into apost-deployed configuration. Also, as the suturing device 400 is removedfrom the opening 210, the length of suture 442 can remain within thetissue 214. Accordingly, the length of suture 442 can close the opening210, after the suturing device 400 is removed from the opening 210.Particularly, as illustrated in FIG. 19F, after the suturing device isremoved from the opening 210 and from the tissue tract 208, the needlecapture devices can be removed from the length of suture 442.Alternatively, the needle capture devices can be removed from theneedles and can remain attached to the length of suture 442.

Thereafter, the opening 210 can be closed to promote hemostasis. Morespecifically, the surgical knot 158 can be formed by tying the ends ofthe length of suture 442 about the opening 210. Thus, the length ofsuture 442 together with the surgical knot 158 can pull together thetissue 214 surrounding the opening 210, thereby closing the opening 210.

The embodiments of the present disclosure may be embodied in otherspecific forms without departing from its spirit or essentialcharacteristics. The described embodiments are to be considered in allrespects only as illustrative and not restrictive. The scope of thedisclosure is, therefore, indicated by the appended claims rather thanby the foregoing description. For example, the sutures described hereincan further be prearranged to define a pre-tied knot, such as thepre-tied knots disclosed in U.S. Pat. No. 7,235,087 previouslyincorporated herein. Additionally, the suturing devices of the presentinvention can further include barbed sutures, or be used to deploycleats or other devices to aid in closing a body lumen opening.Furthermore, where structures, elements, acts, steps, or stages havebeen described with reference to a specified implementation or device;each of the individual structures, elements, acts, steps, or stages, ora combination thereof, are contemplated to be combinable with each otherand with other implementations and devices described herein. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. A suturing device configured to close an openingin a body lumen, the suturing device comprising: a shaft having a distalend and a proximal end, the shaft comprises a plurality of leafs thatdefine the distal end of the shaft, the leafs being configured to flexoutward relative to a center axis of the shaft in response to a forceapplied to the leafs; a first needle lumen disposed within the shaft,the first needle lumen terminating at a first needle exit opening at thedistal end of the shaft; a second needle lumen disposed within theshaft, the second needle lumen terminating at a second needle exitopening at the distal end of the shaft; a guide member slidably locatedwithin the shaft and extending past the distal end of the shaft; a footselectively coupled to the guide member, a proximal end of the footbeing positioned proximally to the distal end of the shaft; a firstneedle capture device removably secured to the foot; a second needlecapture device removably secured to the foot; and at least one length ofsuture secured to the foot, the at least one length of suture having afirst end secured to the first needle capture device and a second endsecured to the second needle capture device.
 2. The suturing device ofclaim 1, wherein: the distal end of the shaft has an tapered cavityformed therein; and a proximal end of the foot has a tapered shapeconfigured to fit into the tapered cavity in the distal end of the shaftin a manner that the foot applies force to the leafs to flex the leafsoutward.
 3. The suturing device of claim 2, wherein the proximal end ofthe foot has a stop surface configured to contact a correspondingportion of the tapered cavity in the distal end of the shaft.
 4. Thesuturing device of claim 3, wherein the stop surface and the taper ofthe tapered cavity and the tapered shape of the foot determine apredetermined position of the flexed leafs.
 5. The suturing device ofclaim 1, wherein: at least a portion of the first needle lumen isassociated with a first leaf of the plurality of leafs; and at least aportion of the second needle lumen is associated with a second leaf ofthe plurality of leafs.
 6. The suturing device of claim 1, furthercomprising a dial adjustment located in the shaft, the dial adjustmentbeing configured to apply force onto the leafs to flex the leafsoutward.
 7. The suturing device of claim 6, wherein the dial adjustmentfurther comprises: a threaded rod that is threaded into a threadedchannel of the shaft; and a wedge coupled to the threaded rod, the wedgebeing configured to apply force onto proximal ends of the leafs to flexthe leafs outward.
 8. The suturing device of claim 1, wherein the shaftfurther comprises a plurality of slots that form the leafs.
 9. Thesuturing device of claim 1, further comprising a first needle and asecond needle configured to engage respective first and second needlecapture devices.
 10. The suturing device of claim 1, wherein the foot isremovably coupled to the guide member.
 11. The suturing device of claim1, wherein the foot further comprises one or more tissue portsconfigured to accept tissue surrounding the opening in the body lumen.12. The device of claim 1, wherein a distal end of the foot has asubstantially conical shape.
 13. A suturing device configured to closean opening in a body lumen, the suturing device comprising: a shafthaving a distal end and a proximal end, the shaft comprises a pluralityof leafs that define the distal end of the shaft, the leafs beingconfigured to flex outward relative to a center axis of the shaft inresponse to a force applied to the leafs; a first needle lumen disposedwithin the shaft, the first needle lumen terminating at a first needleentrance opening at the distal end of the shaft; a second needle lumendisposed within the shaft, the second needle lumen terminating at asecond needle entrance opening at the distal end of the shaft; a guidemember slidably positioned within the shaft and extending past thedistal end of the shaft, the guide member having a first needle and asecond needle, the first and second needles having piercing ends; alength of suture having a first and second ends thereof secured to thefirst and second needles; and a foot coupled to the guide member, thefoot having a first needle connector lumen and a second needle connectorlumen, the first and second needle connector lumens being configured toguide the first and second needles out of the guide member and into thefirst and second entrance openings in the shaft.
 14. The suturing deviceof claim 13, wherein: the distal end of the shaft has a tapered cavityformed therein; and a proximal end of the foot has a tapered shapeconfigured to fit into the tapered cavity in the distal end of the shaftin a manner that the foot applies force to the leafs to flex the leafsoutward.
 15. The suturing device of claim 13, wherein the foot furthercomprises one or more tissue ports configured to accept tissuesurrounding the opening in the body lumen.
 16. A method of closing anopening in a body lumen, the method comprising: inserting a guide memberof a suturing device through the opening and into the body lumen;inserting a foot of the suturing device into the opening and capturingtissue surrounding the opening in one or more tissue ports of the foot;adjusting a shaft of the suturing device in a manner that needle exitopenings located in the shaft correspond with needle capture deviceslocated in the foot, the shaft comprises a plurality of leafs thatdefine a distal end of the shaft, the leafs being configured to flexoutward relative to a center axis of the shaft in response to a forceapplied to the leafs; passing a plurality of needles through the shaft,out of the needle exit openings, through the tissue surrounding theopening, and into corresponding needle capture devices; and retrievingthe plurality of needles together with the corresponding needle capturedevices, thereby passing a length of suture attached to the needlecapture devices through the tissue surrounding the opening.
 17. Themethod of claim 16, wherein adjusting a shaft of the suturing device ina manner that needle exit openings located in the shaft correspond withneedle capture devices located in the foot comprises flexing outward aplurality of leafs comprising a distal end of the shaft.
 18. The methodof claim 17, wherein flexing outward the plurality of leafs comprisespressing a tapered proximal end of the foot into a tapered cavity in thedistal end of the shaft.